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 latest notification by the manufacturer indicates that of the 868 lenses implanted in the United Kingdom, 233 (27%) were explanted due to opacification. The Medicines and Healthcare Products Regulatory Agency - MHRA has established direct communication with specialized professionals who agree to the actions listed above as being the most appropriate.
Causa
Ophthalmic innovations international inc. (oii inc.) has issued a letter addressed to uk health professionals in may 2001 informing their clients of an increased incidence of opacification with the aqua-sense intraocular lens and recommending that monitor their patients in the postoperative period. while the cause of opacification is multi-factorial, studies conducted by the manufacturer indicate that surface calcification appears to be linked to the migration of silicone from the package onto the surface of the lens. no lens has been supplied to the uk since november 2000.
Acción
1) Identify patients implanted with these lenses; 2) Consider contacts with these patients to alert them to a review visit if they are experiencing an opacified vision; 3) Ensure that all patients who have been implanted with affected lenses are aware that they must undergo a review visit if their vision deteriorates in the future; 4) Report all incidents of manufacturer-independent opaque intraocular lens to the Surveillance Unit - UTVIG / GGTPS / ANVISA and its lens manufacturer; 5) Watch out if the UTVIG Technovigilance Unit will publish further information on the Hydroviem IOL opacification incident.
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 information from the Boston Scientific Company of Brazil, this recall was initiated in Brazil on July 19, 2004. In order to ensure that health products are safe and effective, ANVISA, through security measures, through the Technovigilance Unit / UTVIG, asked Boston Scientific do Brasil to keep the UTVIG / ANVISA updated regarding the measures that the company has been adopting in a national context, considering that said product is registered in the National Sanitary Surveillance Agency .//// ///////////////////// BRAZIL 08/30/2004 - In compliance with letter no. 87/2004 UTVIG / GGTPS / ANVISA / MS, dated August 06, 2004 , the company informs that there was no case of death or adverse effect related to the voluntary recall motive (non-emptying of the flask of the release system). It also reports that company representatives have personally checked with and removed all stents that were in stock and that the stents will be returned to the distribution center in Quincy, USA. The UTVIG will continue to monitor all actions collection and return of the product in question.
Causa
Some batches may have undergone a narrowing on the lumen which allows the balloon to deflate. (international recall).
Acción
Boston Scientific of Brazil reports that Boston Scientific Corpration began on July 2, 2004 in a voluntary recall of 2 batches of TAXUS EXPRESS PACLITAXEL Coronary Artery Stent System after it had identified that some of these batches could have narrowed lumen that allows the balloon to deflate.
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 possibility of excessive volume infusion can occur when the machine's initial "O. inrnic" drain alarm is set to "N", and a change in the expected drain volume is performed during the warning: "See drain inic XXXXML" . Essentially, if a very low initial drain alarm volume is programmed into the HomeChoice machine, incomplete initial drainage may occur. If this occurs followed by a complete infusion, the patient may present an excess of volume in his peritoneal cavity and possible adverse clinical reactions due to this excess. The first step to prevent this from occurring is to ensure that the initial drain alarm volume "Init Drain": is properly adjusted when initiating DPA therapy in HomeChoice and discourages subsequent changes in the program. The initial drain alarm volume "Initial Drain AI:" must be adjusted in the "Set Parameters" menu. 70% of the last volume infused in the HomeChoice or manual CAPD exchange is generally considered an initial percentage to determine the optimal setting of the initial drain alarm volume. If the initial drain alarm volume is set to a low volume in software versions 8.5 and later, HomeChoice will automatically alert the user to "View drain inc. XXXXML" at the start of each therapy. DPA. This will allow the user to temporarily increase the initial drainage alarm volume for this therapy, if necessary. This function was designed to meet the needs of those patients who started intermittent DPA therapy with fluid in their peritoneal cavity. If the patient initiates DPA therapy with fluid in their peritoneum, the initial drainage alarm volume should be increased to ensure incomplete initial drainage is not performed. If you have determined that a low initial drain alarm volume is most appropriate for your patient and the alarm volume is currently at "N", you must necessarily change the initial drain alarm volume that is "N" to "OML "in the" Set parameters "menu. If in future the patient's prescription requires that the initial drain alarm volume be temporarily increased using the "See drain inc .: XXXXML" function, this will ensure that the "Drain Low" function is activated. is fully active to prevent incomplete initial drainage. If you have any questions about this, please contact your Baxter Hospitalar Ltda representative, call the service center at 0800 12 55 22, option 3 or send an e-mail to Product Specialist, Edméia Mariani, edmeia_mariani @ baxter.com. The Technovigilance Unit / ANVISA will be following the corrective actions carried out on the machines with software versions 8.5 and later.
Causa
Faced with a customer complaint, baxter has confirmed that machines with software versions 8.5 and later may eventually cause excessive volume infusion in patients.
Acción
The company will be forwarding pages of the HomeChoice Patient Handbook that provide instructions on how to increase the initial drainage alarm volume, "AI drain inc:" permanently or temporarily, and providing a list of your patients performing home DPA. Ask me to review it and make sure it is complete. It further requests that this information be communicated to all its patients, based on the knowledge of its prescriptions and the operation of HomeChoice. Complete the response form that was sent to you and return it by fax to Baxter to the number indicated on the form itself. Returning this completed form will ensure that you have been informed and forwarded to all of your patients affected by this action.
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
Verify that you received a letter from Medivax Industria e Comércio Ltda., Identify and isolate the product Dengue - Fast IgG and IgM strip test in your inventory, and send them to Medivax under the care of the responsible technician. For more information, contact Medivax by phone at (21) 2283-2833 or your local representative. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
Causa
Deviation of quality, and the product may present a false negative result.
Acción
The importing company is providing to its customers the immediate withdrawal of the said product from the market due to deviations of quality.
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
In Brazil - The company informs that no card was imported until the precious moment. Only 06 units of the N Vision Clinician Model 8840 programmer were imported in August 2004 but have not yet been used as there are no 8870 software application cards available. It further informs that this recall is limited to software application cards and does not include other equipment and accessories and no action to patients on this recall is required. Clarifies that it has developed a software replacement version AAA02 that provides additional information and clarifications of the time intervals designed to assist the user in the risk of error in data entry. These software application cards were distributed from December 2002 to May 2004. As of May 2004 Medtronic Neurological no longer distributed these cards. For more information, contact Medtronic by telephone at the above number or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
Causa
Medtronic has received overdose notifications associated with the use of the above-mentioned software cards when users mistakenly enter the periodic bolus interval value in the minutes field instead of entering them into the programmer's hours field. 4 patients with serious injuries and 2 deaths may have resulted from this problem. the manufacturer declares that this subject is limited to software cards when they are used to program synchromed and synchromed el pumps and does not include sybchromed ii pumps or any other equipment. the company has developed replacement software to reduce the risk of error in data entry. the manufacturer started a recall by letter dated august 2004 and states that half of the affected software cards were replaced in early august 2004.
Acción
Check receipt of the letter dated August 2004, two attachments and Medtronic acknowledgment form. Identify and segregate any affected product in your inventory. Remove the infusion pump scheduler application card, and identify it with the software version following the instructions in attachment 1. If you have card programmers with software in AAA version 02, proceed as follows: (1) Complete the acknowledgment form, and return it by mail to Medtronic at the address below. (2) Contact Medtronic at (800) 328-0810, ext. 88608, USA or your local Medtronic representative outside the US to notify you of the number of affected cards in your inventory and to request updated versions. (3) Upon receipt of the updated cards, return the old cards to Medtronic by mail at the address below using the shipping envelope provided. If you need to use the infusion pump programmers before completing this recall, make sure during programming that you have selected the appropriate time field when entering the duration time or the interval time following the instructions in annex 2. If you already have AAD 02 version software updated on your infusion pump scheduler, or if you no longer have any affected products in your inventory, complete the recognition form, and return it to Medtronic by mail at the address below. Re-insert the AAD 02 card application following the instructions in Appendix 1, and continue using it. For more information, contact Medtronic by telephone at the above number or your local Medtronic representative.
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
Check your stock, if you have stocked kits, collect and return immediately to the company, correctly filling out the return certificate sent by the company. For more information, contact BIOMERIEUX BRASIL S / A by telephone at (0xx21) 2444.1400 . The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
Causa
High and unexpected values of controls using fibriquik.
Acción
The company informs that it has received some customer reports regarding the high and unexpected values of the controls using Fibriquik. These reports were confirmed during the internal investigations. It was found that the altered values are due to low levels of thrombin activity in the flask, causing prolonged coagulation times and some imprecision. However, internal research has shown that this does not compromise patient outcomes. Detailed internal studies were performed to demonstrate that international standards, label values, and plasma levels of patients recovered from standard curves using Fibriquik that have less activity than standard thrombin are comparable to those obtained with Fibriquik that has normal levels of thrombin activity . Since we identified products with lower than normal levels of thrombin activity, which could cause undesirable imprecision, we request that the use of the aforementioned Fibriquik batches be suspended.
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
Considering paragraph 3 of art. 111 of the Internal Regulations approved by ANVISA Ordinance No. 593, dated August 25, 2000, republished on December 22, 2000; considering art. 2 and 12 of Law no. 6,360, of September 23, 1976; considering art. 10, items I and IV, of Law No. 6,437, of August 20, 1977; considering the CVS 206-GT Correlates / DITEP communiqué, 8 July 2004
Causa
Because it does not have the manufacturer's operating authorization and does not have a record in this 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
Considering the provisions of paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering item X, of Article 10, of Law No. 6.437, of August 20, 1977; considering Arts. 6, 12 and 25-§ 2 of Law 6360 of September 23, 1976 c / c Arts. 7, 14 and 35 of Decree No. 79094 of January 5, 1977; considering paragraph 2 (a) of Part 5 of Resolution RDC-185, dated October 22, 2001 c / c Art. 9 of Resolution RE-444, dated August 31, 1999, with CERTUSP / USP / IEE / Document No. 2004EC01CE004, dated 05/01/2004, informing the cancellation of the product certification process; considering Arts. 7, III, XIV, XV, XXIV and Art. 8, VI of Law 9782, of January 26, 1999
Causa
Failure to comply with the legal provisions determined in the technical regulations, in the form of health legislation regulating medical products.
Acción
It determines, as a measure of sanitary interest, throughout the national territory, the suspension of importation and sale.
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 company reports that although there is no case registered in Brazil and even if the differences found do not interfere in the diagnosis of the patient, since the clinical picture, the anamnesis, the physical condition and other complementary tests subsidize the diagnosis, to advise clients to use non-reagent tubes when clinical trials for determination of T3, T4 and Cortisol are performed on the following equipment: Total T3 - The use of BD Vacutaine® tubes without plastic gel separator (dry glass can be used as long as users have established their own reference values using glass tubes) //////////////////////////// T 4 Total and Cortisol - It is recommended to use BD Vacutaine® tubes without plastic or glass separator gel
Causa
Routine tests performed in the united states have identified that when these tubes are used in certain equipment the test results may be high compared to the unreacted tubes which are the tubes traditionally used for these types of determinations.
Acción
Both BD and equipment manufacturers are keen to understand the source of the differences in results to see if additional corrective or preventive action is needed. Verify that you have received a letter from the company BD with the following content //////////////// To: Customers using BD Vacutainer® SSTTM and SST ITMI (glass and plastic gel tubes) tubes for determinations of total T3, total T4 and cortisol in the DPC immunoassay system IMMULITE®, IMMULITE® 1000, IMMULlTE® 2000 and IMMULlTE® 2500.//////////////// Dear Customer, We have seen, by means of this, inform them that through routine tests it was identified that the values of total T3, total T4 and cortisol, when obtained through the use of BD Vacutainer® SSTTM and SST IITM tubes (glass and plastic gel tubes) were elevated compared to tubes without gel separator when determinations were performed on the DPC IMMULITE®, IMMULITE® 1000, IMMULITE® 2000 and IMMULITE® 2500 equipment. We know that the results of these hormones should be interpreted with regard to the clinical picture, anamnesis, physical examination and the other subsidiary exams of the patient and. However, we report that the finding problem, although transitory, was only present in tubes manufactured in the United States and Europe. However, preventively, we recommend that the T4 total and cortísol total IT tests, when performed in these equipment, be collected in tubes without gel separator, according to the catalogs suggested in the annex. We would like to point out that all the measures have already been taken to understand the origin of the difference in results. We thank you in advance for your attention and we are at your disposal for any further clarification through our Scientific Advisory 51859960.
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
Serum creatinine is used to measure and monitor renal function. A falsely elevated patient outcome may lead the physician to believe that the patient has kidney failure. Dialysis may be performed without need. This may lead the doctor to believe that the patient is normal or has abnormal kidney function. A falsely low value may lead the doctor to believe that the patient has normal renal function, when this is not true. Incorrect doses of medications can be administered causing intoxication. A Customer Letter has been distributed to all AEROSET and c8000 customers, recommending discontinuing the use of this kit and storing it for later return to Abbott Laboratories. This communication was distributed to all Aeroset and C8000 customers who received lot 14032HW00. - Identify if you are using or have in stock the product CREATININ LN 7D6420 batch 14032HW00, discontinue use of the product, store the mentioned products in your laboratory for later return to Abbott Laboratories of Brazil Ltda - Diagnostics Division, - Fill in the response protocol and ship to 0xx11 - 5536 7181, for further return. Abbott will perform the material collection and will arrange a refund as soon as possible. Additional information contact the Customer Service Center by calling 0800 119099.
Causa
Presence of a precipitate in creatinine reagent i (r1) and inconsistent patient results.
Acción
An investigation was initiated to identify the cause of the precipitate. Investigation to date has determined that the precipitate would not be present in all Creatinine R1 Reagent cartridges of the specified batch.
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 failure of the CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYN 3000 Equipment in flagging a sample with a falsely high WBC count due to the presence of an interfering substance may cause the results of Patient's WBC are reported incorrectly and therefore result in a negative effect on patient safety. This does not affect user safety. Labeling is affected because the Operations Manual states that the WOC can be reported if there is no other suspect parameter signaling. In the customer complaint that initiated this action, the sample report did not present any suspicious parameter, but the WOC count was inaccurate and therefore could not be reported. To date, no damage has been associated with this occurrence in the CELL- DYN 3000, CELL-DYN 3500, CELL-DYN 3000 and CELL-DYN 3000. · Review all CELL-DYN 3000 Series Equipment Operation Manuals to determine if interference information (WBC count in the presence of NRBCs and missing ability to provide accurate WBC counts in the presence of NRBCs) require revision. · Update Operational Manuals (CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYN 3000) as needed to include NRBCs as a potential interference to WOC counting, and information on how to proceed interference.
Causa
Discrepancy in the results of the total white blood cell (vbc) count in the sample of a thalassemia patient, when using the cell-dyn 3700 equipment. the result of cell-dyn 3700 for woc (optical white cell count) was significantly higher than the wbc count determined by the manual method. the source of interference for the woc could not be determined through the information received from the client, but it should be noted that the nrbcs (nucleated red blood cells) present in the sample were being included in the woc, making the count imprecise. the woc parameter is available on the cell-dyn 3700, cell-dyn 3500 and cell-dyn 3200 devices.
Acción
The WOC parameter is available on the CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYM 3000 equipments. Note that the WOC on the CELL-DYN 3000 is called the WBC (total white cell). The WOC in these equipments was designed to apply thresholds, which exclude NRBCs from the WBC analysis. This ability is reflected in product labeling, which currently states that the WOC will provide an accurate estimate of WBCs in patient samples containing NRBCs. While this is true for the vast majority of samples, an investigation by Abbott demonstrated that the WOC result in CELL-DYN 3700 was significantly greater than WBC as determined by haemocytometry in a patient with a high number of NRBC s (> 100 NRBC / 100 WBC s). We are therefore taking the opportunity to inform users that this phenomenon may occur, and also to review the Operations Manuals to reflect this information. ACTIONS REQUIRED WIC ALERTS. WOC or KWOC - If a reported WBC value displayed on the screen your analyzer has one of the WIC, WOC or KWOC descriptor alerts next to it, refer to the list of potentially interfering substances in the Operation Manual for your CELL-DYN 3000 Series Equipment, and follow your lab procedures to confirm the result. ALERTS for NRBC - If a reported WBC value displayed on your analyzer screen has NRBC signaling next to it, review the smear to check for NRBCs and follow your laboratory's review criteria. If NRBCs are present, these should be quantified according to your laboratory procedures. If WBC correction is required, proceed as follows: · On the CELL-DYN 3500 and CELL-DYN 3700 Instruments, correct the WIC value and use the resulting number to confirm the WOC result. If there are no other suspicious signs, the corrected WIC (or WOG value confirmed) can be reported. · On the CELL-DYN 3200 instrument, analyze the patient sample in the NOC mode, correct the NOC value and use the resulting number to confirm the WOC result. If there are no other suspicious signs, the corrected NOC (or confirmed WOC value) can be reported. · On the CELL-DYN 3000 Instrument, check a smear for the presence of NRBCs and check the WBC count by an alternate method. If you have sent your CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 or CELL-DYM 3000 to another laboratory, please provide a copy of this letter to you.
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
Any questions regarding the information contained in this release, please call the Customer Service Center, Tel 0800-11-9099- Abbott Diagnostics Division. This Product Information has been developed by the Abbott Diagnostics Division to inform you of the change in the CELL DYN® 4000 WBC Reagent Part ANA list: 01H77-01.
Causa
The abbott diagnostics division has adopted a new supplier of saponin, used in the cell dyn® 4000 wbc reagent part a. tests have indicated that the new formulation, with the new supplier of saponin (used to lyse the red blood cells), can generate a slight increase in flag rrbc (resistant red blood cell). a total of 119 samples, including 68 abnormal samples, were tested with the following results: · 2 samples with rrbc flag, with the current formulation (lower than batch no. 18087-12) · 5 samples with rrbc flag, with new formulation ( above the lot # 18087-12). you may notice a slight increase in the rrbc (resistant red blood cell) flag for lot # 18087-12 or higher.
Acción
File this release in the CELL DYN® 4000 Operator's Manual, and fill out the Response Protocol and send via fax Fax: 0XX 11 - 5536 7181
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 were notified through the Customer Letter accompanied by Response Protocol. While Abbott investigates the cause of this occurrence, all batches of AxSYM ß-hCG Total Reagents are being placed into an internal monitoring program. If you have any questions about the information contained in this release, please contact the Customer Service Center. 0800-119099.
Causa
Possible cause of error 1048 (cal a / b ratio toa large). although the calibration curve of the assay with these batches is valid, patient outcomes may demonstrate an elevation when compared to other batches. it is not expected that this occurrence, change the results obtained as negative «5 mlu / ml) to positive (> 25 ml / ml).
Acción
¿The AxSYM Total ß-hCG assay is intended for early detection of pregnancy. Detection of very low levels of AxSYM Total ß-hCG is not a rule of no pregnancy. This is because the values double approximately every 48 hours in a normal pregnancy. Patients with very low levels of ß-hCG should be re-collected and this sample should be retested after 48 hours. For diagnostic purposes, the results of hCG should be used in conjunction with other data; symptoms, results of other tests, clinical data, etc. Ectopic pregnancy can not be distinguished from normal pregnancy only by hCG assays. While investigations for lots 172020100 and 175560100 of AxSYM Total ß-hCG. not distributed in Brazil, are in progress, the Abbott Laboratories Division Diagnostics by precautionary measure, recommends the following procedure for all batches of AxSYM Total ß-hCG:. All samples should be initially processed without dilution, if the result is> 1000 mlU / mL, then the dilution protocol (1/10 and 1/200) may be used. The Abbott Laboratories Diagnostics Division is continually working to complete this investigation as soon as possible. We apologize for the inconvenience this has caused to your laboratory.
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 discrepancy exists between the number of characters allowed in the result that is sent to the ARCHITECT System (20 characters), and what is described in the ARCHITECT System's Standard RS-232 Interface Manual (15 characters). This manual states that the maximum number of characters allowed in the result field (ASTM Field 10.1.4) is 15 characters. The client uses the manual specifications to configure your server for bidirectional communications with the ARCHITECT System. When a client configures its server to accept only a result containing 15 characters or less, based on the RS-232 manual, and the ARCHITECT sends a result that is longer than 15 characters, it may not be accepted by the server or may be truncated. For example, if ARCHITECT sends "gray-zone reactive" text and the client server recognizes only 15 characters, this text may appear on the server as "gray-zone react", or the server may reject the entire transmission record, so that the data is not displayed. The server determines which of these results can occur, based on its schedule. If your ARCHITECT Analyzer is not connected to a Laboratory Information System (LIS) and / or if you are not using ARCHITECT Software Version 2.00 or higher, please disregard this information. ADDITIONAL INFORMATION Any questions or additional information, please contact the Abbott Customer Service Center Diagnostics Division - Phone 0800-11-9099.
Causa
Discrepancy that exists between the maximum number of characters defined in the abbott rs-323 standard interface manual for the data value field and the number of characters that the architect software may attempt to send to this field.
Acción
Corrective action for this occurrence is an update to the ARCHITECT Equipment RS-232 Standard Interface Manual to reset the maximum number of characters in the ASTM field from 15 to 20 characters. Immediate Action: Customer Letter (Important Product Information) has been distributed to all ARCHITECT customers who have ARCHITECT Software Versions 2.00 or higher. Future Distribution of Information: The current ARCHITECT i2000 module customers with Software version 1.6 were not affected by the occurrence. ARCHITECT i2000 clients upgrading to Version 2.1 software are not affected by this occurrence. Software modifications affecting the ARCHITECT System RS-232 Standard Interface Manual related to ASTM 10.1.4 Field are contained in version 2.00 or higher, and are applicable only to c8000 modules where user-defined testing is used. Abbott trials are not affected by this modification. New Customers - The ARCHITECT System RS-232 Standard Interface Manual, Listing No. 06F71-04 was placed in Quality Quarantine, 1016-2004. The product will be destroyed and a corrected version of the manual will be released, Listing No. 06F71-05
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 is actively developing a software update designed to avoid programming a parameter-sensitive combination, the accompanying programming recommendations eliminate the risks associated with early device replacement due to this behavior of the device. CRT devices most commonly programmed for simultaneous BiV pace pacing (LV offset = zero) or sequential BiV where LV precedes RV (negative LV compensation value) are not subject to the risks described in this letter. 1. Review the patient schedule records deployed with the CRT devices included in Appendix B of the Charter. 2. If the LV Compensation parameter is set to Zero or a Negative value, the device is not at risk of this behavior. 3. If the LV Compensation parameter is set to a Positive value, determine whether the following conditions are met: A. The positive LV Compensation value exceeds the Ventricular Atrial Post-Ventricular event, where blanking "Smart" is equivalent to a value of 37.5 ms; and B. Scheduled Trace Preference for ON 4. For patients whose device has a LV Compensation value exceeding the Atrial Blanking value after ventricular event, the Trace Preference is set to ON, schedule a clinical review to reprogram the CRT device as follows, according to the individual medical needs of the patient: A. Program the CRT device so that the post-ventricular Atrial Blanking is greater than the value of the positive LV Compensation; or B. Disable the Trace Preference by programming it to a value of "OFF". 5. Devices with an Atrial Blanking post-event ventricularexcedendo the value of Positive LV Compensation are not affected and are not at risk of this behavior. 6. Patients whose device has the Scheduled Tracking Preference OFF are not affected and are not at risk from this behavior. If a positive LV Compensation is desired for a newly implanted Boston Scientific CRT device, consider the patient's individual medical needs and schedule the ventricular post-ventricular Atrial Blanking greater than the value of Positive LV Compensation, or disable the Trace Preference by scheduling it to "OFF". 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
Boston scientific initiated a voluntary notification of important programming information to avoid unintended asynchronous biventricular pacing (biv) behavior by tracking elevated atrial intrinsic rhythms in certain pacemakers (crt-ps) and defibrillators (crt-ds) cardiac resynchronization therapy (crt). repeated detection of this unwanted asynchronous biv rhythm pacing behavior may result in the implanted device reverting to a permanent safety core ™ situation, thus requiring an early replacement. unintended asynchronous biv pacing pacing behavior can only occur where an infrequent combination of parameters is programmed, specifically: • left ventricular compensation (lv) programmed to a positive value that exceeds post-ventricular atrial blanking (blank-a after rhythm -v); and • trace preference = on (nominal). devices not programmed in this way are not affected. we apologize for any inconvenience this action may cause, and appreciate your understanding as we take action to ensure patient safety and customer satisfaction. we are committed to continuing to deliver products that meet the highest quality standards you expect from boston scientific.
Acción
Field Action Code 2017-011 triggered under the responsibility of Boston Scientific do Brasil Ltda. Will make 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
A falsely elevated Uric Acid result may cause unnecessary treatment. There is no impact to the user's health or ability to use the product if the instructions guidelines. Increasing Uric Acid results can be identified with quality assay samples every 24 hours using the current quality control recommendations contained in the Uric Acid Reagent Application Sheet for the AEROSET Equipment. If the values of the controls are high, the patient's results between the time of the high quality control test and the previous quality control test with acceptable result should be reviewed. If you have any further questions or concerns, please contact the Abbott Customer Service Center - Diagnostics Division - Phone 0800 119099
Causa
When a uric acid cartridge, lot number 95015hw00 is placed in the apparatus and calibrated, samples and / or qc material can be raised to 1.1 mg / dl (0.07 moi / l) in a 24 hour period between the control trials. not all cartridges within this batch have been affected.
Acción
Customer Letter was distributed to all customers who received lot number 95015HW00, recommending discontinuing the use of this lot number. This corrective action was implemented in March 2004. It is important that the following actions be taken: • Identify whether you are using or have in stock the AEROSET Uric Acid Reagents product, lot number 95015HW00. Discontinue use of batch number 95015HWOO, segregate kits from affected batches, and wait for collection of this material, by Abbott Laboratories. Will Abbott Laboratories provide replacement product for all Uric Acid kits destroyed from lot number 95015HWOO. Please complete the Response Protocol and return it to Abbott as instructed. Follow your laboratory procedures to verify the accuracy of test results and to communicate with health care providers for whom you provide services. Keep this release in the permanent archive of your laboratory. ¿If you have sent AEROSET Uric Acid Reagents, lot number 95015HW00 to another laboratory, please provide a copy of this notice to this one. During the investigation of the cause of this occurrence, it is recommended as a precautionary measure that the frequency of quality control monitoring for Uric Acid from two levels of controls (normal and abnormal) be increased every 24 hours for each 8 hours.
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
When these error codes occur, the user is notified by changing the color of the icon in the Error Code screen. Lower level error codes (that is, level 3 error messages), as defined by the manufacturer, may have an influence on the generation of patient outcomes. Higher error code levels will cause not only the color change of the icon, but will also cause a change in the processing status of the RUNNING AEROSET Analyzer to PAUSE. The user should evaluate the error code and take the necessary steps to finalize the processing before reporting the results. There is no effect on the health or ability of the user to use the equipment. This occurrence was identified internally during the development of user needs for a next generation of AEROSET Family Member equipment on 6 February 2004. As part of the system review for continuous improvements, the error message database was the appropriate levels setting. When one of the Error Messages listed in Table 1 is generated, an "HW" Result Error Code will be generated. Until your laboratory is able to complete the actions required above, follow these steps: Customer Letter accompanied by Response Protocol for the sole AEROSET customer in Brazil. If you have any questions or concerns, please contact the Abbott Customer Service Center ¬Division Diagnostics - Telephone 0800-11-9099.
Causa
The aeroset® biochemical analyzer and accessories and their software are performing performance as designed and in accordance with the product labeling. as part of an internal system review for continuous improvement, the database of error codes was revised to the levels of error codes configured on february 6, 2004. a total of 18 level 3 error codes were identified as required for reclassification to a higher level, level 1. these levels of error codes are used to determine how the equipment communicates with the end user when error messages occur.
Acción
Customer Letter accompanied by Response Protocol was sent to all AEROSET customers, providing instructions to the user on how to change the status of the error codes identified in Table 2 above. These modifications to the error codes will be included in the next release of the AEROSET Analyzer Software version 1.03ER000, eliminating the need for users to manually change the status of error codes using the above mentioned instructions. The projected date for release of this software is the 4th quarter of 2004
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 this situation occurred only for the ARCHITECT i TESTOSTERONE Reagent LN 6C28-20 and 6Cc28-25 assay, and was not observed for the other assays of the ARCHITECT line. Currently in Brazil, the ARCHITECT TESTOSTERONA Reagent, is not being marketed. If you have questions about the information contained in this release, please call the Customer Service Center, Tel .: 0800-11-9099.
Causa
The abbott diagnostics division determined that the current architect i septum n ° list: 4d18-01, when used in conjunction with the architect assay. testosterone reagent ln 6c28-20 and 6cc28-25 could generate a contamination. this would be possible because of this contaminant present in the current architect i septum n ° list: 4d18-01, have similar chemical structure and compete with testosterone binding sites. with the new architect i septum n ° list: 4d18-02, this contaminant has been eliminated.
Acción
Reconstruction of ARCHITECT i Septum. The new ARCHITECT i Septum N ° List: 4D18-02 is being replaced by the current ARCHITECT i Septum N ° List: 4D18-01, used with all ARCHITECT assays. The new ARCHITECT i Septum N ° List: 4D18-02 can be identified by the white color of the package instead of the actual green color ARCHITECT i Septum List Nr .: 4D18-01.
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 impact on user safety as to the issue of Blast Signaling or platelet aggregation. Letter issued through the company contains clarifications regarding two points in the Cell-Dyn® 200 System Operation Manual: The first amendment aims to clarify under which conditions the instrument can generate a blast flag. The second amendment clarifies the use of the "Dispersional Data Alerts" in relation to the platelet aggregate. Blast Alert The blasts alert currently described in the Manual is based on cases used during the development of the algorithm. These cases indicated that if there were cells at a specific location where the typical blasts are located, corresponding to more than 1% of total WBC, the BLAST alert would be generated. The intention of this standardization was not to establish a mean detection rate greater than 1% of blasts for all Cell-Dyn 3200. WBC blasts have a wide diversity among patients with additional morphological changes due to the treatment submitted to the patient. It is possible that some blasts are not differentiated from normal cells, which can lead to false negative results. As a precautionary measure, the description of blasts alerts was reviewed in Section 3 - Operation Principles, subsection Operational Messages and Data Signaling, as described below: The BLAST alert occurs if the following condition is encountered: the count in the region where the blasts typically localize is> 1% of the total WBC count. Platelet Aggregate The instrument does not always alert results of thrombocytopenic samples that presented platelet aggregate. The equipment may not generate suspect alerts, such as PL T URI (Over the Interference Region) or NWBC (not WBC), which would indicate its presence. The following paragraph should be added Section 3 - Operation Principles, subsection Operational Messages and Data Signaling. It is recommended that each patient's limits be set for each instrument, within the limits specified by the laboratory. If the Interpretation Report option is enabled, Interpretation Messages, such as leukocytosis, anemia, thrombocytopenia, etc., may appear when the result is above the expected limit. For a result above the expected limit the operator must follow the laboratory protocol, which may include sample repetition, notification to the clinician or perform a manual blood revision. When there is a cell abnormality that alters the cell morphology, and the instrument has not been configured for each patient's boundaries, the data scatter message signaling may be the only alert viewed by the operator to identify suspicious results. . Should you need further clarification, please contact the Customer Service Center 0800 119099
Causa
A sample of a patient known to have leukemia was analyzed on a cell-dyn 3200 cs 110 software version 2.0 software and presented a normal wbc count and differential results without suspicious signaling. the sample was analyzed in duplicate on a different cell-dyn 3200 cs and presented normal wbc and differential results without any signaling. a manual differential showed 14% blasts. automatic differential results were not reported outside the laboratory. cell-dyn 3200 cs did not generate a blast signal in a patient sample that presented 14% blasts in the manual differential. the machine's gain settings have been checked as correct. the possible cause for software failure to display a blast signal is the presence of abnormal blast cells, which do not meet the criteria of the algorithm for generating a signal. platelet aggregation: there was a discrepancy in platelet results (plt) of two samples from a single patient due to platelet accumulation during the use of cell-dyn® 3200 cs 110, software version 2.0. the report of the first sample showed marked thrombocytopenia (plt = 34.5 k / μl) with elevated mpv (13.0 fl). the results of pl t and mpv were underlined in the sample report, indicating that the results were outside the laboratory-specific limits, but no other suspected plt signals were generated. these results were reported outside the laboratory. a second sample from the same patient was analyzed. this report showed marked thrombocytopenia (plt = 16.1 k / μl) with normal mpv (9.65 fl) and no suspected plt signal. the plt result was underlined in the report indicating that the result was outside the laboratory-specific limit. however, the revision of the blood slide in the second sample showed accumulation of plt. the second sample was then incubated at 370c for 15 minutes and analyzed in repetition. results of heated samples showed a normal plt count (plt = 343 k / μl) with normal mpv (10.5 fl) without suspicious signs. these heated sample results were reported outside the laboratory with a note indicating that the plt count may not be accurate due to the presence of platelet aggregates. this appears to be a sample related issue involving plt-specific cold agglutinin. the buildup becomes too large to be detected and therefore is not flagged. the plt results from both samples were underlined as being outside the laboratory limits, but no other suspicious signals were generated by the cell-dyn 3200. reviewing a blood smear from the second sample showed the presence of platelet aggregates. based on the data provided by the customer for the two samples in question, this may not be confirmed if the accumulations of interfering platelets meet the criteria for signal generation. the alerts generated by cell-dyn 3200 for the two samples in question were scatter data alerts; the underline of plt results that were below the limits established by the laboratory. with any scatter data alert, the laboratory protocol for review of flagged results must be followed. describe the effect that the occurrence with the product may have on the patient's health and / or the user or ability to use the product as indicated on the label: blasto signaling: the cell-dyn 3200 cs is an automatic equipment for the production of results in patient samples. in the reported failure, the apparatus does not produce a blast signal when it is present in a patient sample. blasto cells are abnormal cells, produced in hematological diseases, such as leukemia. failure to detect the presence of blast cells may cause the physician to delay the diagnosis of leukemia. this can result in complications. plaquetary aggregate: o.
Acción
Customer Letter Customer Response Protocol All customers of the CELL-DYN® 3200 CS and SL Equipment received the communication. In Brazil, the Letter to the Client was accompanied by a Response Protocol. Communication in Brazil was initiated on: March 25, 2004. ACTIONS REQUIRED It is important that the following actions be followed: Please place this important Product Information in your Cell-Dyn 3200 System Operation Manual Section 3 - Principles of Operation, subsection, Operational Messages and Data Signaling. Please follow your laboratory procedures to communicate the health institutions that are serviced by your laboratory. If the Cell-Dyn 3200 has been relocated to another laboratory, please provide a copy of this letter to them.
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
No medical damage or events have been reported on the CELL DYN 3200 equipment when using Diluent / Sheath CD 3200 lot number 10055310747 between February 24, 2004 and September 10, 2004. Always make sure that the background counts are in of the specifications before testing controls and patient samples. If the control results are within acceptable limits, but background counts are out of specification, DO NOT TEST SAMPLES OF PATIENTS. If contaminated reagents are suspected, this may have contaminated the Diluent / Sheath filter. Consequently, the filter must be changed before using the reagent batch. Filter torch instructions are found in the Monthly Maintenance Section of Chapter 9: Services and Maintenance. If the Diluent / Sheat CD 3200 with lot number 1795412 is in stock, discontinue using the lot listed if the platelet count is above 0.5 / ul as mentioned in the CD 3200 Operating Manual. Continued use of the said lot if the platelet count is up to 0.5K / ul. Fill in the Response Protocol for later return of the product. Abbott Laboratories will collect the material and provide a refund. Contact your Abbott representative to request a replacement. For any additional questions or concerns, contact the Abbott Customer Service Center Diagnostics Division Telephone 0800-11-9099.
Causa
Some bottles of diluent / sheth cd 3200, lot 1795412, showed a higher than expected platelet count when used in the cell-dyn 3200 device. tests have identified a contaminant trace in the reagent that appears to be the cause of or a factor contribution to high platelet counts. analytical tests indicate that the contaminant is a high boiling oil, which may form an emulsion in the reagent as a result of agitation and aging. it is believed that the emulsion is raising platelet background counts.
Acción
The source of such contaminants and / or any composition factors is under investigation. The initial action consisted of an increase in recently-sampled lots of Diluent / Sheath CD 3200 made for platelet background counts. Additional actions will be determined on the basis of the results of the research
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
Note the existence of abnormal platelet histogram with an MCV <7) fl parameter, as it may be a case of microcytosis and thrombocytopenia, with no URI alert message appearing. According to the results, of red blood cells and platelets, by an alternative manual or automatic method, according to the laboratory procedure. The platelet histogram demonstrates a normal or typical platelet histogram, which should be considered as the visual validation criterion of the result. As well as, patient boundaries indicate an abnormality of outcome, and are used to repeat and confirm by alternative methods manual or automated, according to the laboratory procedure. You are requested to: Keep a copy of the communication received in your files and attached to the CEL-DYN 1400, 1600 and 1700 instrument manuals. Forward a copy of the communication to the physician. Fill in the RESPONSE PROTOCOL and send the Customer Service Center. Any additional questions or clarifications, please contact the Customer Service Center, Telephone 0800 119099
Causa
Software-related occurrence: the algorithm that governs the uri signaling mechanism inhibits the display of the signal for blood samples that are characterized by low values in certain areas of sample histogram. a blood sample with combination of thrombocytopenia and microcyst of red blood cells is not likely to trigger uri signaling. the design of the software in combination with the characteristics of certain patient samples is the cause of the occurrence.
Acción
Investigation into the cause of occurrence was completed. An initial preventive action was implemented. The initial preventive action consists of a review of the impact of this occurrence on other CELL-DYN Séire 1000 platforms. The CELL-DYN 1400 and CELL-DYN 1600 analyzers have essentially the same platelet algorithm as the CELL-DYN 1700. They may, however , exhibit the same URI signaling behavior for platelets with respect to thrombocytopenic / microcytosis samples, such as those of patients with thalassemia and idiopathic thrombocytopenic purpura.
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
For questions or clarification, contact the Abbott Diagnostics Division Customer Service Center at 0800-11-9099, or your local representative. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
Causa
It was found that the tdx-tdxflx dilution buffer, when used with the tdx-tdxflx benzodiazepines (urine) assay, may cause changes in control values and patient outcomes. preliminary results from an ongoing investigation indicated that the occurrence is associated with the vial in which the tampon was filled. the magnitude of the effect is directly proportional to the time the buffer is stored in the bottle. studies in abbott have shown that the occurrence does not affect other tdx-tdxflx assays. when using a single batch of tdx-tdxflx dilution buffer, you may observe that the test control values and patient results decline in the absence of recalibration. when introducing a new batch of tdx-tdxflx dilution buffer, and values are read from a stored calibration curve, increasing or decreasing changes in control values and patient outcomes may be observed. the magnitude of the change observed during internal testing was 33.4 ml at 200 ng / ml of 25.7 ng / ml and 26.6 ng / ml at 1000 ng / ml. according to the labeling of the product, the tdx-tdxflx benzodiazepines test provides only initial analytical results. a more specific alternative chemical method should be used to obtain a confirmed analytical result. there were no claims, damages or medical events that could be attributed to this occurrence.
Acción
Customer letter with label for each system (with Return of Receipt - AR) and Quality Policy for the Customer Service Center. Actions Needed: During the use of a single batch of buffer, recalibrate the TDx-TDxFLx Benzodiazepines assay every 14 days. Perform a new calibration on the TDx-TDxFLx Benzodiazepines test when a new TDx-TDxFLx lot number is used. Dilution Buffer. These actions are in addition to the calibration and quality control requirements of the instructions for use. Follow your laboratory procedures for notification to the health professionals you serve. If the TDx-TDxFLx Dilution Buffer (list number 9519-02) and / or TDx-TDxFLx Benzodiazepines (list number 9674) has been sent to another laboratory, provide a copy of the letter and inform all operators of the TDx-TDxFLx System about this release. For future reference, insert the notice in the TDx-TDxFLx system operation manual
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
Air in the blood line can cause gas embolism in hemodialysis patients. Issuance of letter to the clinicians responsible for the devices and hemodialysis therapy reporting of the corrective action to be performed in the manuals of the machine operator. If you have any questions, please contact Baxter technical support by calling 0800 12 55 22, option 3 or e-mail the national director of technical services, carmine_maglio@baxter.com. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
Causa
Reports of air bubbles were observed in the blood line, after the air detector, without sounding the alarm warning the operator of the possibility of air in the blood line.
Acción
One review showed inadequate use, including failures in the practices commonly observed in hemodialysis. The company informs that it has updated Operator's Manuals and training guides to clarify the instructions and add caution and caution phrases to call attention to the possibility of air entering the extracorporeal circuit and to clarify methods for withdrawing air from the circuit.
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
Although the possibility of this type of event occurring is remote, it presents potential risk due to the shock. If you find it difficult to turn the machine on or off, or if you notice that the power switch is loose, immediately unplug the machine and contact the technical service by calling 0800-125522 option 3 for orientation. According to Company information, no similar occurrence was reported by its customers in Brazil. The UTVIG / ANVISA - Tecnovigilância Unit will be following the entire process of updating the HomeChoice machines until the moment of its closure.
Causa
Reports from patients who received electric shock using homechoice. investigation conducted through the company baxter healthcare corporation, route 120 & wilson road, round lake, 60073-0490, confirmed that the homechoice machine's on / off switch pin loosened, causing a circuit breaker. this key is not grounded.
Acción
All HomeChoice machines are being upgraded with on-off switches. All new and refurbished machines, manufactured after August 1, 2004, have a grounded on / off switch.
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
Verify that you received the letter from Empresa Biomérieux Brasil SA, requesting the non-use of the product, until the collection of the table with the correct values. Identify and isolate any affected product in your inventory. For more information, contact your local representative or your own company by calling 0800264848. For further information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone ( 61) 448-1485.
Causa
Occurrence of error during transcription of inr value - for a time of 20.9 seconds and a reference time of 11.0 seconds, the inr is 3.85 and not 6.85.
Acción
The company decided to inform its customers immediately of not using the product, until the collection of the table with the correct values. Block the marketing of the product, and adjust the corrected table in the Blocked Kits.