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
The products were not sterilized and could be offered criminally in health services.
Causa
The company embramed reports the theft of products that were intended for sterilization, according to boletim de occurência no 4177/2011, of the 33rd dp -pirituba, issued on 07/29/2011.
Acción
For all services and professionals, check the origin of Embramed products, avoiding the acquisition of the products listed in the annex.
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
According to Politec Ltda, the product manufacturer (Bard Access System Inc.) started collecting the product due to constant complaints about valve breakage. This problem causes leakage of gastric contents and feed solutions, resulting in inconvenience to the user. According to the company, no damage, in addition to slight skin irritation, has been reported with valve breakage. UTVIG / Anvisa is following up on this case.
Causa
The manufacturer of the product (company bard access systems) is collecting the product on the world market due to continuous valve breakdown claims.
Acción
The holder of the registration of the product in Brazil informed the UTVIG / Anvisa that it has already begun sending letters of communication to the distributors / users of the product, as well as the collection of affected lots. According to the company, it is not necessary to remove the already deployed devices. The user of the product should take the following measures: (1) Check for affected products in stock; (2) If affected products are found, immediately cease their use and distribution, segregating them immediately - identify with a label, to avoid inadvertent use; (3) Return the affected products to the registry holder Politec Imp. and Com. Ltda (address in the field Manufacturer's description) or to a distributor of the product; (4) Fill in the Product Collection Form (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/951_carta.pdf) and send it to Politec Ltda, according to the instructions on the form itself.
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
According to Toshiba Medical of Brazil Ltda., When there is a failure in the power supply, the immediate interruption of the x-ray generation occurs, and then the warning message "Abnormal XC Status" is shown to the user. In this way, according to the company, the failure in question does not produce damages to patients and users. If you need to contact the company to handle this case, the contact is as follows: Adriano Bordignom (Technology Manager), Tel. (11) 4134-0063. UTVIG / ANVISA is following up on this case.
Causa
The power supply that controls the x-ray generating unit fails.
Acción
The holder of the product registration informed that he has already begun, on 05/01/2009, the process of correcting the problem - by changing the power supplies of the equipment under risk. To the users of the product it is recommended, if the equipment presents the warning message (ABNORMAL XC STATUS), contact the local technical assistance of Toshiba medical do Brasil Ltda (check the address and telephone number in the Manufacturer's description field.
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
The reason for product repair is related to one of the batches of the relay (electronic component) involved in the release mechanism of the equipment's electrical discharge (defibrillation). Such components may undergo premature degradation, cease to function before the programmed time and thus render the defibrillator inoperable. The manufacturer informed that it has already sent a technical newsletter to its sales representatives, informing the procedures for forwarding the products to be corrected. The Technovigilance Unit is following up on this case.
Causa
One of the parts (relay) of the equipment may degrade prematurely, compromising the operation of the product.
Acción
Recommended actions for product users are as follows: (1) Check if there is any equipment affected by this alert in your Health Facility; (2) If any, segregate the affected equipment (s), replacing it with equipment (s) in good conditions of use, if possible; (3) Identify the equipment (s) segregated with a poster or banner so that they are not inadvertently used; (4) Please contact the manufacturer / recorder of the product registration (Transform Tecnologia de Ponta Ltda.), Informing that you have equipment under risk in your Health Care Center. The identified products must be sent to the Technical Assitance of the factory , which will perform the exchange of components that present a risk of failure.
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
Boston Scientific do Brasil Ltda has already started collecting the product. The problem was detected by Boston Scientific Corporation during a quality inspection performed by the company. The Technovigilance Unit is following up on this case.
Causa
The packaging tray of some units may be broken, which compromises the sterile barrier of the product. if used, the potential effect for the patient may be infection.
Acción
Users of the product in question shall: (1) Immediately discontinue use and segregate the collected product; (2) Complete the Verification and Traceability Response Form; (3) Pack / send the affected product. To access the Form of Traceability provided by the company: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/954_formulario.pdf.
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 Ltda reported that it has already begun sending a letter of communication to customers affected by the problem. The updated software version, containing the correction of the problem, is already being elaborated by the company. #### Update on 04/20/2012: According to communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, of 04/19/12), the field action has already been completed - software fix and addendum to the product operation manual.
Causa
The display of an image window acquired with a flat panel optivue (with software version - coherence oncologist - 2.0 or higher) may be offset relative to the reference image.
Acción
Siemens Ltda, the company that owns the product registration in Brazil, informed the UTVIG / ANVISA that it has already begun sending letters of clarification to the customers affected by the problem. If they have not yet received the company's letter of clarification, users who own the equipment should contact the company (see the Manufacturer Description field in this alert). Users who have already received the letter of clarification should attach it in the Coherence Oncologist manual until the software update is run by Siemens.
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
The manufacturer of the product, Ethicon Endo Surgery Inc., detected the problem and found that the presence of free nickel in the product could induce a reaction in patients with nickel sensitivity or even sensitize certain patients exposed to nickel in the future. According to the holder of the product registration in Brazil (Johnson & Johnson do Brasil Ltda), so far no adverse events have been reported so far. Anvisa's Technovigilance Unit is monitoring this case.
Causa
Possibility of degradation of the stainless steel tips of the product, which can result in the release of small amounts of nickel. as a result, there may be a risk to the health of some patients.
Acción
The holder of the product registration in Brazil (Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda.) Has already begun collecting the product and blocking affected batches in the company's inventory. The recommendations to users and distributors of affected products are as follows: (1) Do not distribute the product with the codes and dates described above (in Product Description); (2) Inspect your product stock immediately and remove the affected affected products, segregating them and identifying them to prevent inadvertent use of them; (3) Contact the product registration holder for return of affected products.
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
Baxter is currently developing solutions for correcting the events reported in this letter. The instructions attached to this letter describe further steps to remedy a discontinuation of therapy if it occurs. The ANVISA Technovigilance Unit is monitoring this case.
Causa
1 ° problem: some error codes shown by colleague infusion pumps can lead to interruption of therapy (infusion), which can lead to complications in critically ill patients, including serious injury or death. 2 ° problem: risks associated with inadequate cleaning procedures. 3 ° problem: occurrence of "out of battery" messages.
Acción
The actions recommended to users for each of the reported problems are described in detail in the Letter to Users. Users of COLLEAGUE infusion pumps who do not have a copy of said letter should access it (available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/956_carta.pdf) and carefully read all instructions, taking the necessary measures to correct / prevent the problems mentioned in this alert.
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
The cited problem can occur every time the following events occur simultaneously: a patient is selected in the patient list, the examination tab is pressed and a query to the database is running at the same time in the background. According to Philips Medical System Ltda (holder of product registration in Brazil), the equipment will be updated with a software version that will correct this error. The company has not yet released the timeline for correcting the error. The ANVISA Technovigilance Unit is monitoring this case.
Causa
The equipment may perform an incorrect selection of patients, which may cause confusion of data belonging to different patients.
Acción
The recommended action for product users is that, before saving the images, check the patient selection list if the correct patient is selected.
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
According to a communication letter sent to UTVIG / ANVISA by Siemens Ltda, the company will send a communication letter to its customers. The company also reported that equipment under risk in the country has not yet been installed, that is, they are not yet in operation. #### Update on 04/20/2012: According to communication sent on 04/17/2012, 2012 by the company for UTVIG / ANVISA (file no. 0324770128 of 04/19/12), the company has already closed the field action. The three equipments affected by the problem in Brazil were corrected by the company through a software update.
Causa
The display of the equipment may be misaligned by about 4mm when compared to the reference image. with this, a single exposure image can be overwritten by a dual exposure image.
Acción
The company that owns the product registration, Siemens Ltda, has not yet begun to communicate with users affected by this alert. According to the company, to avoid the possibility of overwritten images from a single exposure by a dual exposure image, users should acquire / load images of the same type of exposure during a session. If this recommendation is difficult to implement at the health facility, users are advised to select SAVE (save) to each image immediately after a modification. The ANVISA Technovigilance Unit (UTVIG / ANVISA) is monitoring this case.
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
The use of linear surgical staplers with sharp blades accelerates surgical procedures, replacing manual tissue suturing, makes the procedure less traumatic for the patient, and facilitates the execution of complex surgical procedures more easily for surgeons. However, studies conducted by the US non-governmental research institute (ECRI) have pointed out that misuse of such equipment can cause serious harm to patients. The use of an undersized cartridge (i.e. intended for thin fabrics) in a thicker fabric may prevent the clamps from firmly contacting the anvil and folding in their fully closed form. Thus, these clips can work freely, allowing the clip line to open. Likewise, using an oversized cartridge in a thinner fabric allows the clips to contact the anvil and be folded in the correct shape, but the clips will not completely compress the target tissue. Although the staples remain in place, the resulting openings in the staple line may allow leakage between the tissue halves. Even after selecting the clamp size based on the estimated thickness of the tissue, the surgeon may find a tissue that is thicker or thinner than originally assumed. For example, liquids may continue to leak out of tissue after it has been grasped at the jaws of the stapler, causing the tissue to become thinner than originally estimated. Source: ECRI Institute. Using the wrong size surgical stapler cartridge can injure patients [hazard report]. Health Devices 2009 Apr; 38 (4): 129-30.
Causa
Incorrect use of linear cutter surgical staplers in various procedures including resection, transection, and anastomosis may cause severe adverse events to patients.
Acción
The following actions are recommended to users; (1) The surgical team should be aware of the problem and the recommendations of this alert; (2) Keep staple cartridges of different scales available during the procedure, enabling them to be promptly replaced where necessary; (3) Correctly match the cartridge of clips to the estimated thickness of the target tissue, taking into patient the additional buttress thickness, if present; (4) Before firing the stapler, make sure that the staples are actually appropriate for the procedure, since the difficulty of grasping the fabric or reducing the thickness of the staple (leakage of liquids for example) may indicate the need to resize the staples. Bobby pins; (5) Ensure complete closure and hemostasis of stapled tissue; (6) Maintaining alternative means of closure and hemostasis, as investigations conducted by ECRI have pointed out that incidents of severe injury or death are associated with non-use of alternative closure methods (eg hand sutures or other stapler); (7) Report incidents involving surgical staplers to manufacturers and Anvisa (NOTIVISA).
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
The potential effects of the problem are as follows: (a) Delay in surgery caused by the need to restart the insufflator; (b) Delay in surgery caused by need of replacement of the insufflator; (c) If the shut-down occurs and there is no alternative equipment available, there is a risk that the surgery will need to be converted into open surgery; and (d) if the device shuts off during surgery, there is a risk of accidental cutting of the patient's internal organs. Stryker do Brasil Ltda informed that, between January 13 and 16, 2009, the PneumoSure software was updated on all customers affected by the problem. For more information, access the Letter to Product Users (available at www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/960_carta.pdf). UTVIG / ANVISA is following up on this case.
Causa
Sudden equipment shutdown may occur. the equipment can be reconnected, but with the risk of recurrence of the fault at any time.
Acción
The recommended actions for product users are as follows: (1) Check if there is any equipment in your inventory that is affected by this alert; (2) If you locate any affected equipment, check if it has already been corrected in relation to the problem mentioned (check the maintenance records - if you have any questions, contact the registry owner); (3) If the affected equipment has not yet been corrected, segregate it immediately, identifying it properly (with a poster, for example) to prevent inadvertent use of the equipment until the problem is corrected; (4) Contact the record holder (see address in the Manufacturer's description field) and report the existence of equipment at risk.
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 Ltda informed the ANVISA's Technovigilance Unit (UTVIG / ANVISA) that has already sent a communication letter to its customers, reporting the problem and advising on the necessary actions. The company also reported that it intends to update all AXIOM ARTIS systems that cause the problem reported in this alert, but has not yet reported the start date of the field action to be performed. #### Update on 04/20/2012: Accordingly with communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, 04/19/12), the field action has already been finalized - software correction. The company reported that it performed the correction on ten equipments installed in Brazil.
Causa
When a specific sequence of actions is performed, the generated images may be corrupted or contain non-clinical measures. the problem is related to the use of qva, qca or lva quantification software in combination with certain versions of axiom artis software.
Acción
Recommended actions for product users are as follows: When using the "Catheter Calibration" method as the basis for QVA, QCA or LVA quantification, the operator must not change the selected image after selecting the calibration method; that is, the calibration image should be selected before "Catheter Calibration" is started. Once "Calibration by Catheter" is selected, the image can no longer be changed. If your health care facility has affected equipment, contact the product registration holder to inform them and ask for the necessary steps to correct the equipment.
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
According to Abbott Ltda, the problem is noticeable during the preparation of the material - hence, therefore, of the stent implantation in the patient - and does not affect the stent itself. The reason for the recall was the receipt of three case reports by Abbott regarding the problem in the distal rod of the product. The Technovigilance Unit is following up on this case.
Causa
The balloon of the distal tip of the catheter, responsible for the implantation of the stent, may not inflate until the end. this problem may compromise the implantation of the stent in the patient.
Acción
The holder of the registration of the product in Brazil has already begun the communication to the customers involved and the collection of the affected products in the market. Users are advised to: (1) Check for affected batch products in stock; (2) Collect affected products and segregate them, identifying them properly to avoid misuse; (3) Contact the product registration holder in Brazil.
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
The installation of this type of equipment in clandestine workshops or in the health service itself can pose a great risk to the health of the patient, the operator of the machine and other people who transit in the vicinity of where the equipment operates. The granting of registration of the X-ray Equipment in Anvisa is conditional, among other requirements, the presentation of the INMETRO Certification of Conformity of the equipment. In the certification are evaluated, through laboratory tests, electrical safety, mechanical and radiation emission requirements of the equipment, based on specifications established in technical standards of the Brazilian Association of Technical Standards - ABNT; are still evaluated, through factory inspection, requirements of the Quality System of the company with respect to the production process of the equipment. Therefore, considering the nature of the radiation emitted by the equipment, the use of products that have not been evaluated by Anvisa in relation to the compliance with the necessary safety criteria, can pose a great risk to the health of the population, besides characterizing sanitary infraction under the Law 6437/1976. It is still framed in Crimes Against Public Health, in which the offenders are subject to the penalties set forth in art. 273 of the Brazilian Penal Code (Decree Law No. 2848/1940), incurring in the same penalty who imports, sells, exhibits for sale, holds on deposit to sell or, in any case, distributes or delivers the product without registration, when required , in the competent sanitary surveillance body. We inform you that according to RDC Anvisa no. 185/2001 (article 4) medical equipment must have affixed to your body an indelible label that includes: the name and commercial model of the product, your registration number with Anvisa, the name of the its manufacturer and its serial number. To verify the regularization in the Anvisa of the X-ray Equipment and of other medical products, access: http://www.anvisa.gov.br/scriptsweb/correlato/correlato.htm
Causa
The national agency of sanitary surveillance - anvisa - warns about the risks associated with the use of x-ray equipment that are not properly regularized with anvisa.
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
According to the manufacturer of the product, corrective measures to solve the problem in the production process are already being taken. The entire process of withdrawal from the market, rework (where possible), testing and re-release was carried out in accordance with good practices. manufactured and monitored and documented by local health surveillance. It was performed inspection and sent report, as well as the publication in DOE with the respective release.
Causa
Perforation in the wall of blood bags with consequent extravasation of anticoagulant or biological material.
Acción
Users are advised to take the following actions: (1) Check the inventory for products at risk listed in the Product Description field of this alert; (2) Segregate and identify the products at risk located; (3) Contact the supplier / recorder of the product. According to information from the record holder of the product, the affected batches of the product have already been withdrawn from the market by means of a Letter of Communication to customers.
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 has been found that lot 09/3880 of the O'ring 10 mm Labmax 240 product (Labtest 17173 code) may not work properly when installed in the equipment. The malfunction of this component allows the formation of bubbles in the body of the pumps of the modules SP, RP, PWP and CWP or the leakage of liquids, causing the loss of reproducibility of the analyzer. We note that the problem was identified only in lot 09/3880, with different batches being used without any restriction. Items collected will be restarted as soon as a new batch is available. Any clarification please contact the Automation Technical Assistance at 0800 031 34 11. Source: Labtest Diagnóstica S / A. Anvisa is accompanying the action of collecting such equipment.
Causa
Water leakage occurs on the sp / rp / pwp pumps and the cwp module of the labmax 240 equipment due to improper adjustment of the o-ring sealing these pumps.
Acción
Immediate discontinuation of use of this batch. Contact Labtest Automation Technical Assistance at 08000313411.
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
The malfunction described is caused by a problem in the welding process. This was identified due to a batch of printed circuit boards (PCBs), which did not meet Maquet's quality standards. The affected boards are those of Interconnect. The affected batch has number 70218. The affected plates were assembled in the HL20 Twin Pumps TPM20-330 (Art No. 703323), whose numbers of affected series are: 93201074; 93201081; 93201082; 93201083; 93201084; 93201085; 93201086; 93201087; 93201088; 93201097; 93201102; 93201103; 93201105; 93201107. Source: Maquet Cardiopulmonary do Brasil Indústria e Comércio S / A.
Causa
In rare cases, the hl20 tpm20-330 double pump may malfunction when in use in slave cardioplegia mode. the malfunction is that the actual rpm of the pump when in slave cardioplegia mode, in rare cases differs from the selected value. if this malfunction occurs, the safety system will be activated. the safety system will stop the cardiopulgence pump in question and an error message will be displayed on the device's display.
Acción
Recommendations for healthcare professionals: The Interconnection plates of all affected Double Pump Modules should be replaced as soon as possible. Contact your local MAQUET representative to replace the plates of your affected HL20 Double Pumps TPM20-330 (Art No. 703323) with a new one as soon as possible. Caution until corrective action is taken: In order to prevent any unnecessary risk to the patient, the company advises to disconnect, for example, the slave mode in the pump between the administrations of cardioplegia. Additionally, keep the cardioplegia delivery line clamped all the time between delivering cardioplegia to the patient's side in the connecting line.
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
Stryker do Brasil outsources the distribution and technical assistance of this equipment to the company: BIOCAM Rua Dr. Alves do Banho, 890 Campinas - SP CEP 13030-580 Tel. 19 - 3272-3274 e-mail: biocam@biocam.com.br
Causa
The equipment can continue to function even when the trigger is not depressed, potentially causing unintentional damage to soft tissue or bone.
Acción
The actions recommended to the users of the product are as follows: (1) Assemble the battery, connections and drills outside the surgical field; (2) Test the trigger system before the actual intervention. The company that owns the product registration has already ordered the kits for trigger repair, and must obey the attached action schedule. There was customer visitation (see distribution list) with promotion of guidelines and labeling on handpieces.
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
See attachments.
Causa
Paradigm quick set infusion catheter unexpected behavior at the time of the prime manual associated with the saturation of the p-cap opening membrane with silicone oil and therefore not allowing air to escape from the reservoir compartment can prevent ventilation of the pump of insulin, potentially resulting in excess or lack of insulin to be delivered, leading to serious injury or death.
Acción
The actions recommended to the users of the product are as follows: (1) Immediate interruption of the use of infusion kits of this lot; (2) Switch to an infusion kit that has not been affected or implement the injection contingency plan established with your physician; (3) Contact your supplier to arrange for the return and replacement of any Quick Set "Batch 8" infusion kits at no additional charge.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Baxter's safety notice regarding the use of Minicap with povidone iodine
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
See attachments.
Causa
During a procedure, the umbrella - ventricular end - of the agualha leveen electrodes - 5.0 cm, can be released from the central wire, causing bleeding or slight tissue trauma, which may require intervention.
Acción
The actions recommended to users of the product are as follows: (1) Immediate discontinuation of use and segregation of the affected product set forth in this notice; (2) Completely complete and return the Verification and Traceability Response Form to: Boston Scientific do Brasil - a / c Caroline Yin - Phone: (11) 5502-8510 or e-mail: yinv@bsci.com.
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
This situation is restricted to samples of neonates (born up to 28 days) when blood glucose tests are performed with this system and compared with other glucose monitors. In results below 50mg / dl (or 2.8mmol / L), results with negative deviation (lower values) were identified from -7 to - 12 mg / dl (-0.4 to -0.7mmol / L). Internal investigations are being conducted by the company in order to determine the reasons that lead to this deviation of performance. #### 15/10/2010 - After the investigations, the optimized product reached all acceptance criteria, in order to meet all necessary requirements for neonatal dosing. Starting with the 321001 test strip lot, all ACCU-CHEK Performa strips will include the improved calibration process, with performance characteristics for capillary, venous, arterial, and neonatal specimen.VIDE APPENDICES ####
Causa
It was observed that when blood samples of neonates were collected by accu chek performa, low blood glucose values were obtained. see clarifications as the termination of alert.
Acción
The actions recommended to the users of the product are the following: Immediate interruption of the use of this product in neonates.
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 important to note that clinical laboratories use controls capable of identifying this type of quality deviation, since changes in creatinine levels may indicate renal impairment. By means of the traceability of the affected lots, the communication was made to the customers (see annex), informing them of the fact. The process of collecting the lots is already underway and Anvisa follows the process. ### The company informed the closing of the field action through file 842387 / 09-3 of 10/27/2009.
Causa
By means of studies carried out by the manufacturer, the loss of stability in a specific lot of the raw material dissodiohydrogen-phosphate, causing a decrease of stability in the creatine reagent, has been identified, being able to lead to falsely low results.
Acción
The actions recommended to users of the product are as follows: (1) Immediate discontinuation of use and segregation of the affected product set forth in this notice; (2) Contact your dealer or distributor (see attached list)
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
We are aware that hospitals often remove the products from their outer packaging and store them on hospital shelves, only in their internal pouches. If this is a practice in your unit, it is very important that you carefully use the table below and consider both the internal code and the external code of the product packaging when searching for affected products of this voluntary recall, since UPN Codes on the labels of the inner packagings of the product are different from those on the outer packagings. The product information listed on your specific Verification and Traceability Response Form (which is attached to this alert). Source: Boston Scientific. ### Update on 11/09/2009 - The company informed Anvisa of the closure of the action for the collection of the affected products through file 749932 / 09-9 dated 10/01/2009.
Causa
It was identified during a manufacturer's inspection and testing process that the torque conductor used to insert the set of screws that connect the control wire to a cross pin of the resolution® clips device was out of calibration. this may result in an inability to position or release catheter.
Acción
The actions recommended to product users are as follows: (1) Immediate discontinuation of use and segregation of the affected product in this alert. (2) Complete and return the verification and traceability response form to: Boston Scientific of Brazil - A / C: Carolina Yin - Fax: (11) 5502-8510 or e-mail: yinc@bsci.com.