Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
JG Moriya recommends to all users that they never attempt to operate the product without prior knowledge of proper usage instruction or supervision. Do not use the product if leaking and missing parts are found. Do not smoke in the area where the equipment is used. Never use oil, grease, hydrocarbon or leave similar organic materials in contact with oxygen, under risk of explosion. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 10/13/2016 - Date of notification notice to Anvisa: 12/16/2016 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The federal hospital customer of andarai on 11/11/2016 informed jg moriya that the macronebulizer sealing ring, lot 0000041305, deformed after the disinfection and sterilization process. the hospital reported that it uses peracetic acid to perform these processes. it has also been reported that in the manual does not specify the correct way to assemble the product after cleaning, making it difficult for the operator at the first moment to assemble correctly.
Acción
Field Action Code RRC-006/16 triggered under the responsibility of the company JGMoriya Representation Importadora Exportadors e Comercial Ltda. It will update, correct or supplement the instructions for use.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Siemens recommends a re-examination of the "Safety" section of the user manual with the establishment's employees and make sure that this warning is included in the system instructions. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 06/27/2017 - Date of notification notice for Anvisa: 07/20/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Siemens healthcare diagnostics sa informs that through field action mi009 / 16 / s has notified customers of patient positioning instructions must be respected so that patients' hair is not trapped in the patient bed rise / fall units. field action mi010 / 16 / s deals with the effective field correction of the problem described (exchange of parts and parts) and the present field action mi011 / 17s is a check of the actions performed.
Acción
Field Action Code MI011 / 17 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA will perform a check.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Cobas and 411 customers: The actual manufacturer of the product, Hitachi High Technologies Corporation (HHD, will fix this error in the Sample & Control; data file with a new software version.) This new software will prevent samples from being requested and executed on the cobas and 411 when the Sample & Control data file is full Distribution by the manufacturer of the next version of the software is scheduled for the fourth quarter of 2017. Roche Diagnostica recommends performing the following actions until the new SW is installed: • Perform the "Sample Data Cleai "Sample Data Clear" is step 2 in the Workflow Guide in the "System Overview" window. Note: Cleaning the sample data eliminates all sample results and transfers the QC data to the QC viewing window. It is recommended to perform the backup procedure regularly, depending on the vo and its local regulations. If your system is connected to a server, verify that all data has been loaded before performing sample data cleaning. • When the new SW version is available, it must be installed as a mandatory update on the system. Elecsys 2010 Customers: Roche Diagnostica recommends performing the following actions daily: • Delete open, unprocessed or unordered samples (if appropriate) on the "Order" screen • Exclude documented samples from the "Result" ) If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. If you are a professional or an Institution / Entity, if you are a professional of an institution / entity, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option. access through the link - Date of identification of the problem by the company: 06/21/2017 - Date of notification notice to Anvisa: 07/20/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Roche diagnostics gmbh, the legal manufacturer of the product, informs its customers and users that, in very rare cases, software malfunction (sw) may occur in the sample & control data file; (revision of results) and may cause a potential incompatibility of data. this sw malfunction only occurs: • when the "sample data clear" function is not performed daily as indicated in the operator's manual, and • when the sample & control; and • when the elecsys 2010 analyzer's sample & contro; / (revision of results) data file is occupied with> 600 records.
Acción
Field Action Code SBN-CPS-2017-011 released under the responsibility of Roche Diagnostica Brasil Ltda. You will upgrade the Software.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Segregate the affected lots for later exchange for products with the appropriate labels. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 03/07/2017 - Date of notification notice to Anvisa: 07/21/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Once a product label has been identified as faulty, the information "prohibited reprocessing" has been mistakenly replaced by the terms "single-use product" and "non-resterilize", in breach of current legislation.
Acción
Field Action Code 111/2017 triggered under the responsibility of the company VENTURA BIOMEDICA LTDA. Will perform pickup.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Segregate the affected lots for later exchange for products with the appropriate labels. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 03/07/2017 - Date of notification notice to Anvisa: 07/21/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
An error was identified in the labeling of the product / lot (s) below valve for hydrocephalus synchrony - cello series / - anvisa registration no. 10175060021 auto089833, auto089833, auto089753, auto089691, auto089754, auto089689, auto089748, auto089749, auto089839, auto089838, auto089485, auto089521 , auto089571, auto089601, auto089633, auto089693, auto089834, auto089844, auto089692, auto089755. the labeling of affected lots is missing the information "prohibited reprocessing", which was mistakenly replaced by the terms "single use product" and "do not resterilize", in disregard of current legislation. this failure does not interfere with the effectiveness and functionality of the product and poses no risk to the patient, since important information for the safe use of the product is present on the label and in the instructions for use of the product.
Acción
Field Action Code 80/2017 triggered under the responsibility of the company VENTURA BIOMEDICA LTDA. Will perform pickup.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Since the intended use of the monitor is intended for healthcare establishments under the supervision of qualified users (hospital staff), the use of monitors should be discontinued until the software is updated to eliminate the problem. If it is necessary that they be kept in use for a period of time, we recommend that the monitors be monitored constantly to identify if the monitor is faulty to trigger the apnea alarm. Customers who own these monitors will receive an information letter. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 02/28/2017 - Date of notification notice to Anvisa: 07/21/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The reported problem occurs in the efficia vital signs monitor, models cm120 and cm150, software version: b.01.00 (041), when these models are in use with rack efficia (ref 863331) and external etco2 modules from dixtal: capnostat 5 (ref dx-alco2-0) and microstream (ref dx-alco2-1). philips healthtech - pcms - vss brazil has identified, through internal testing, a software anomaly that prevents the sound alarm from being triggered. under certain circumstances, a software error may lead to a situation in which the sound of the apnea alarm is not emitted. the visual alarm will continue to function normally. other related alarms (low fr, low etco2, etc.) are not affected by the problem. to date, there are no reports of adverse events related to this problem.
Acción
Field Action Code DEDF1704 triggered under the responsibility of Philips Medical Systems Ltd. Will update the Software.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
There is no additional action related to this recall for patients who were previously treated with the possibly affected product. These patients should continue to be monitored according to each institution's standard treatment protocols. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 10/07/2017 - Date of notification notice to Anvisa: 7/13/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Medtronic has been reported to have difficulty in removing the stylet and there is a risk of damaging the balloon or catheter due to excessive force applied, this may lead to changes in balloon insufflation or deflation.
Acción
Field Action Code FA779 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA Company will make payment.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Comply with the guidelines indicated on the product label on 2 hour onboard stability. And also follow the guidelines sent through alert. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 06/28/2017 - Date of notification notice to Anvisa: 24/072017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
According to the stop shipment document h2017-015 sent by the manufacturer on 06/28/2017, during the stability factor test on board the acl top (equipment), hemosil factor xii deficient plasma failed to meet the criteria of 24 hours. after stability testing, the onboard stability period of the related lots was changed to 2 hours. on 12/07/2017 was sent an instruction and labels for the identification of the product with the new term stability on board. forms for inspection, control and registration of labeling implementation were also reissued.
Acción
Field Action Code H2017-015 triggered under the responsibility of the company Werfen Medical Ltda. Will update product label and customer communication.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
It is recommended that venipuncture should occur prior to the administration of sulfasalazine or sulfapyridine. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 06/29/2017 - Date of notification notice to Anvisa: 07/21/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Siemens healthcare diagnostics has identified possible sulfasalazine and sulfapyridine interference in assays using nadh and / or nadph to generate oxidation reduction reactions producing colorimetric signals.
Acción
Field Action Code CHC 17-06 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Issue letter to the client.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
As the products have not reached users and patients, no recommendation is needed. The distributor has already been informed and is taking the necessary actions. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/14/2017 - Date of notification notice to Anvisa: 08/01/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Zimmer biomet is conducting a very specific recall of medical devices for vanguard open posterior stabilized femoral components due to the inadequate labeling of some components between april 5, 2016 and september 1, 2016. as a result, the packaging of some femoral components was incorrectly labeled with smaller or larger size and / or wrong side (right / left). at the moment of use, it is easy to detect the incorrect label, since the product has correct laser marking. the estimated occurrence rate is <1 in 1,000 products.
Acción
Field Action Code 2017-274 triggered under the responsibility of Biomet 3I of Brasil Comércio de Aparelhos Médicos Ltda. It will make collection for return to the manufacturer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Software update must be performed for fault correction. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 04/07/2017 - Date of notification notice to Anvisa: 07/28/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The company has identified that: 1) when the language of the cios alpha system is set to english and the date format yyyymmdd is used, the patient's date of birth when received through a dicom worklist will be displayed with the month and day reversal, this is for patients who have birth dates between days 1 and 12. 2) a system pause may occur during dvd recording if the dvd icon in the flc status bar is blinking. 3) sporadically the system may not be ready for radiation during the reclosing of the car to the main unit.
Acción
Field Action Code XP057 / 15 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA will update the Software.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Stop using the batch in question. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/27/2017 - Date of notification notice to Anvisa: 07/27/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
High reactivity index for aslo (false positive) in the stress reagent tests (accelerated stability). follow-up tests were carried out on the kits of these batches, subjecting it to a new accelerated stability, where an increase in sensitivity was identified. samples with values lower than 200 iu / ml (but close to this value) began to present positive reactivity, in this way it is directed to perform the collection to avoid future problems in the diagnoses.
Acción
Field Action Code Recall AEO Latex - Cat.541 and 541L triggered under the responsibility of the company Gold Analisa Diagnóstica Ltda. It will collect and return to the manufacturer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Following our Risk Management policy of medical-hospital material, we informed all Health Units that purchased the products from lots 314322043 and 314147218 that there is a divergence in the label compared to that registered with Anvisa. In the event of any adverse events related to these lots, please be informed immediately so that we can take appropriate action. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 02/19/2016 - Date of notification notice for Anvisa: 03/08/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The tpd-48120 disposable pressure transducer hosp trad had its commercialization and use suspended in february 2016 due to divergence of labeling. the product has not been marketed since the suspension and all customers and distributors have been alerted to the problem. the analytical report 695.1p.0 / 2016, issued by lacen-df, identified that the information on the labeling and the contents of the primary packaging differ from the information contained in the product registration. for this reason, anvisa determined the collection of lots 314322043 and 314147218.
Acción
Field Action Code AC01 / 17 triggered under the responsibility of the company Hosp Trade Do Brasil Eireli - EPP. Collection and destruction of the product.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
RECOMMENDATION TO USERS AND CUSTOMERS: Whenever an "Abnormal L2-line Movement" alarm (P. Pipetting level) is issued by the system and the immunochemistry module (cobas and 602 module, cobas and 601, and E170) is in "Pipette Stop", perform the following steps to determine if a sample result mismatch (provided the "Tip / Cup pick up error" alarm has occurred a few minutes before the "Abnormal L2- line Movement ": 1) Collect the remaining racks of the system. Stand-Alone Systems: a) Wait until the system status becomes Stand-By. b) Perform the "Reset or Rack Reset" to collect the racks for Unloader. Systems connected to laboratory automation: a) Stop sending automation racks from the lab and wait until all results to measure the sample output. b) Press the "Stop" button to make the system status enabled for Stand-By. c) Perform the "Reset or Rack Reset" "Reboot or Reboot Racks" to collect the racks for Unloader. 2) Identify and handle the misconfigured rack and incompatible samples Appendix 1 "Identifying and Handling Possible Alternate Sampling Results in cobas e602" Appendix 2 "Identifying and Handling Possible Alternate Sampling Results in cobas e601" Attachment 3 " How to Identify and Treat Possible Alternate Sample Results on the E170 "3) Delete the sample measurement results that were identified as incompatible on the Workplace> Data Review screen. 4) Perform measurements again for the identified samples. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 06/22/2017 - Date of notification notice to Anvisa: 07/24/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Roche diagnostics gmbh, a legal manufacturer of the product, informs its customers and users that, in very rare cases, a sample incompatibility may occur in the immunochemistry modules (cobas and 602, cobas and 601 and e170 modules) due to a software limitation. sample incompatibility is caused by a software limitation and occurs only if the following conditions are met simultaneously (ie, very rare occurrence): • the immunochemistry module (cobas and 602, cobas and 601 and e170 modules) must be included in its respective system (cobas 8000 modular analyzer series, cobas 6000 analyzer series, modular analytics, modular analytics evo). • the "module rack buffer setting" setting ≠ "1"> two or more sample racks remain on the waiting line / line (l-line) consecutively during operation. • one rack (rack a) is being pipetted into the sample and the next rack (rack b) is waiting for measurement. • the gripper (t / v conveyor) can not pick up the last cup in rack a. as a result, the measurement of the sample in the last cup, which has not been picked up, is canceled and the "tip / cup pick up error" (caution level) is issued • the rack position 1 of the next rack (rack b) is empty or has no test request for the immunochemistry module.
Acción
Field Action Code SBN-CPS-2017-012 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Software Update.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
As the labeling failure does not pose any risk to the user or the patient when using affected batches, the manufacturer only advises the user to seek guidance: "The Manufacturer Recommends Single Use" - as a way of clarifying its correct use. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 03/07/2017 - Date of notification notice for Anvisa: 03/08/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
A fault was identified in the product / lot label (s) below. product: hemostatic clip - registration anvisa nº 10175069002 lots: auto089768, auto089789. the labeling of affected lots is missing the information "the manufacturer recommends single use", which was mistakenly replaced by the terms "single use product" and "do not resterilize", which should not be present on the labeling. does not interfere with the efficacy and functionality of the product and poses no risk to the patient, since its only consequence is to restrict the user to single use of the product, rather than just recommend single use.
Acción
Field Action Code 109/2017 triggered under the responsibility of Ventura Biomedica Ltda. Company will report that there are untrue statements on the product label ..
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
If the affected product has been safely used, then no further action is required. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 03/28/2017 - Date of notification notice to Anvisa: 04/07/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "#### UPDATED ON 08/17/2017, the company sent the completion report of the field action proving the accomplishment of correction as planned.
Causa
Between the dates of july 20 and november 7, 2016, 5 complaints were received alleging magnetic resonance artifact caused by the wire locating to rm ghiatas. no lesions have been reported in the patient. through further investigation, it was confirmed that some rm ghiatas wire packages contained non-rm compatible ghiatas wires made of t304 stainless steel instead of wires for rm ghiatas made with 625 inconel. in mri, the use of a non-rm locating wire instead of an mr-compatible locating wire would create an image artifact. the mri artifact allegedly caused by the mama ghiatas localization wires may be associated with a varying degree of physician dissatisfaction as well as harm to the patient. the presence of an artifact on mri is undesirable and may potentially have serious clinical implications. however, regarding the placement and use of locating wire, there are other viable means to ensure that the intent of the wire, which is to take the surgeon to the area of injury, can still be achieved with a high level of success.
Acción
Field Action Code No code triggered under the responsibility of the company Bard Brasil Indústria e Comércio de Produtos Medicos Ltda. It will collect and destroy the product.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
1. If there are products in stock, immediately discontinue use of the product and segregate them in quarantine and request recall. 2. To return the product, complete the recall form and send to the distributor or via email tecnovigilancia@tctecnicacirurgica.com. This will allow you to identify the number of products in stock for return. A representative of the distributor who has carried out the commercialization of this product will contact you and guide you in the best way to return these products. 3. If you do not have any quantity of the affected product in stock, please complete the collection form, send it to the distributor or via e-mail to tecnovigilancia@tctecnicacirurgica.com. This will confirm that you have received this collection notice. There are no users / patients affected by this issue. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/13/2017 - Date of notification notice to Anvisa: 08/01/2017 The company that owns the product registration is responsible for contacting its customers in a timely manner in order to guarantee the effectiveness of the ongoing Field Action. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Reason for voluntary field action notice: the manufacturer is initiating a recall of the control tip microline tips product (graspers and dissectors) due to the possibility of containing a defect related to the heat-shrinking insulation tube, located near metal tip. there are no reports of injury to the patient associated with this problem.
Acción
Field Action Code 001/17 triggered under the responsibility of the company Tradehosp Trade of Products for Health Eireli-EPP, which will make collection.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Action: We ask customers / distributors to check in their inventory the aforementioned lots. Please segregate material for WAMA to perform immediate replacement. Also inform all the direct customers (laboratories) who have bought that we will exchange their stocks. Batches made from this date will be accompanied with greater sampling to follow the effectiveness of the actions taken to regularize the test (AC 20170748). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/21/2017 - Date of notification notice to Anvisa: 07/28/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
According to customer complaints and internal analysis of the quality control, there was a high reactivity index for aslo (false positive). in the confirmatory tests with the kits returned by the customer and kits of accompaniment the origin of the complaint was observed. several comparative analyzes were carried out confirming the problem with the batches affected, according to the documentation and analysis report of the quality control of wama, sent to the clients.
Acción
Field Action Code 001-B / 17 triggered under the responsibility of the company Wama Produtos Para Laboratórios Ltda. Pick up and return to the manufacturer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Action: We ask customers / distributors to check in their inventory the aforementioned lots. Please segregate material for WAMA to perform immediate replacement. Also inform all the direct customers (laboratories) who have bought that we will exchange their stocks. Batches made from this date will be accompanied with greater sampling to follow the effectiveness of the actions taken to regularize the test (AC 20170748). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/27/2017 - Date of notification notice to Anvisa: 07/28/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Problem: according to customer complaints and internal analysis of quality control, there was a high reactivity index for aslo (false positive). in the confirmatory tests with the kits returned by the customer and kits of accompaniment the origin of the complaint was observed. several comparative analyzes were carried out confirming the problem with the batches affected, according to the documentation and analysis report of the quality control of wama, sent to the clients.
Acción
Field Action Code 001-A / 17 triggered under the responsibility of the company Wama Produtos Para Laboratórios Ltda. Pick up and return to the manufacturer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Read and follow the Important Field Security Notice (371-01-MSQ-011). Once received, perform the actions described in the IFSN and sign the receipt, sending it to your Elekta representative as soon as possible, but within a maximum of 30 days. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 05/24/2017 - Date of notification notice to Anvisa: 07/08/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
We received the information about the table offset in the vertical direction, which was reversed. an investigation confirmed that the inversion occurred during cma (couch move assistant) use and only on the vertical axis. an inverse change will result in the patient being out of position for twice the magnitude of the change. for example, if a displacement of 1 mm in the wrong direction has occurred, the patient will be 2 mm from the desired position. the machine characterization (mac) file is critical to the correct operation of mosaiq and elekta linac. elekta became aware of this issue on june 24, 2017 of a customer complaint (02364349), reported in the field in germany. a total of 26 patients with more than 50 events where treated outside the intended position.
Acción
Field Action Code FCA-IMS-0024 triggered under the responsibility of the company - Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Correction of parts / parts.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Be aware that closed bottles of Batch K4852 can no longer be stored refrigerated to check the performance of VITROS AST or ASTJ Slides. Discard any remaining stock refrigerated stored if used to check VITROS AST or ASTJ Slides. Keep this notification as a verification of the revised instructions. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Instructions for use indicate that the closed vitros performance verifier ii may be stored frozen until the expiration date or refrigerated for ≤6 months. stability tests determined that the closed bottles for lot k4852 did not meet the 6-month specification of the product when stored refrigerated. all other lots are not affected. our data indicate that quality control results generated with vitros ast slides were negatively biased outside the 2 standard deviation (sd) limit for refrigerated stored closed bottles. vitros astj slides are affected in a similar way. the frozen stored product is not affected by this problem. customers can continue to use the frozen stored product until the due date.
Acción
Field Action Code TC2017-132 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Field correction.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Customers and users are advised not to over-tighten the bolts when reinstalling the cover after maintenance. When removing screws for maintenance, avoid touching the edge of the USM Cover. If you want to notify technical complaints and adverse events use the following channels: Notivisa: Adverse Event (AE) and Technical Complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Roche diagnostics gmbh, a legal product manufacturer, informs its customers and users of the c501 and c502 modules that an operator was injured during a maintenance task by removing the cover of the ultrasonic homogenizer (usm cover 3) from a cobas c 502 module whereas cobas c 501 and cobas c 502 modules share the same hardware, roche diagnostics gmbh, manufacturer of the product, decided to inform and require operators of both systems to carry out the maintenance task with special care in order to avoid the occurrence of accidents.
Acción
Field Action Code SBN-CPS-2017-015 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Software Update.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Patients receiving IABP therapy are in critical condition and sudden cessation of therapy may result in unsafe hemodynamic instability. Follow the instructions below when using an affected IABP CS100i, CS100 or CS300: 1) Under the WARNINGS section of our IABP CS100i, CS100 or CS300 Operator's Instructions, clinicians are instructed not to leave the patient unattended during therapy with IABP. 2) An additional hazard associated with a sudden withdrawal is related to the static (non-inflating or deflating) condition of the balloon during cessation of therapy. It is important to note the following WARNING in the IABP CS100i, CS100 or CS300 Operational Instruction Manual. WARNING: The patient's flask should not remain inactive in the patient (ie, not inflate or deflate) for more than 30 minutes because of the potential for thrombus formation. 3) Until service is performed, we recommend that the IABP be connected before inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to complete. If the IABP fails to successfully complete the self-test and shows the test failure code 58, remove the IABP from the service and contact your Maquet / Getinge Sales and Service Office. In the unlikely event that a sudden cessation of therapy occurs, transfer the patient to an alternative LPAI. If an alternative IABP is not available, inflate the IAB manually with air or helium and aspirate immediately. Refer to the instructions for use of the intra-aortic balloon catheter, Manually Inflating and Deflating a Catheter. The IAB Instructions for Use reiterate that a catheter should not remain inactive for more than 30 minutes because of the potential for thrombus formation. Alternatively, the intra-aortic balloon catheter should be removed from the patient. The patient should be treated according to the treatment protocols of the unit and with the clinical judgment of the care providers to ensure hemodynamic stability. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Maquet / getinge received a complaint involving an iabp cs300 that did not work due to an electrical test failure code at 58 (ventilation initialization tests fail), maintenance code no. 3, and a self-fill failure, which were associated with the death of a patient due to failure of the device to initiate therapy. an electrical test failure code 58 is caused by a solenoid valve that requires more power than the solenoid control board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve to not open. this is recognized by the system as an electrical test failure code at 58 when connecting to iabp. units distributed after december 11, 2013 are not affected by field correction. maquet / getinge is working on replacing the solenoid control boards. replacing the board requires a service representative to perform the service on the cs100i, cs100, and cs300 iabps.
Acción
Field Action Code 2249723-4 / 27 / 2017-001-C triggered under the responsibility of Maquet Cardiopulmonary Do Brasil Industria E Comercio Ltda. Field correction.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Since there were no sales of the tables still in Brazil, as they are still in stock in our distributor there is no need to indicate recommendations to users and patients. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
During the quality inspection routine carried out by the manufacturer, some screws on the surgical table did not have the desired fixation, which can affect the stability of the table and in extreme conditions causing critical failures.
Acción
Field Action Code AC 008-17 triggered under the responsibility of the company VR Medical Importadora e Distribuidora e Produtos Médicos Ltda. Adjustment for tightening screws.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Customers / users who have purchased batches related to this notification are advised by telephone and email to always follow the guidelines of Good Laboratory Practice and perform (pass / rotate) a control by replacing the R2 reagent bottle. If the recovery of the control shows a deviation of more than +/- 15% from the previous results, recalibration is required. In addition, an internal statement will be posted on the carton kits that are still in stock, reminding you of the need to use one control at each R2 bottle exchange for re-calibration of the assay, if necessary. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/14/2017 - Date of notification notice to Anvisa: 08/17/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Biosys ltda., the registered trademark holder, has received a statement from the international manufacturer of the product, diasys diagnostic systems gmbh, stating that individual bottles of reagent r2 may show a change in coloration, which may lead to deviations in results, due to the increase in reagent blank. the deviation in the result can only occur if an unmodified reagent bottle r2 is replaced by another bottle of modified reagent r2, or vice versa, without further recalibration. thus, the risk of a deviation from the patient's outcome is only associated with replacement of r2 bottles without recalibration, since reagent performance is not affected, even with the more intense staining of some r2 bottles. biosys informs that it has not received a customer complaint related to the products in question.
Acción
Field Action Code 4529 triggered under the responsibility of the company BIOSYS LTDA. Company will update the instructions for use.