Alerta De Seguridad para Baxter and Althin dialalizers: (1) a-11, (2) a-15, (3) a-18, (4) a-22, (5) af-150, (6) All batches with the following product codes: (1) unidentified, (2) 237015, (3) 237018, (4) 237022, (5) 238015, (8) ax1500, (9) ax2200, (6) 238018, (7) 238022, (8 and 9) 239015, 239022, 239522

Safety alert

386

2001-11-16

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Baxter international has announced the discovery of a probable cause for the deaths of the 53 patients who occurred during the past month in establishments that use the above dialyzers. after extensive research, baxter discovered that the problem occurred in dialyzers containing perfluorohydrocarbon, a fluid used in the manufacture of about 10% of dialyzers manufactured at baxter's ronneby facility in sweden. perfluorohydrocarbon is a liquid at room temperature but turns into gas if it is warmed to body temperature, meaning that gas bubbles may have entered the bloodstream during hemodialysis, resulting in death of patients. perfluorohydrocarbon is not used in the manufacturing process for other dialyzers that baxter manufactures or distributes. baxter international has announced that it will permanently discontinue this way of manufacturing dialyzers as a precautionary measure. baxter, the fda and international regulatory agencies are continuing investigations to see if chemical fluid has been used by other filter manufacturers and whether other patients may have been affected. baxter international inc [305486], one baxter pkwy, deerfield il 60015.

After numerous investigations, Baxter identifies probable cause of recent deaths from hemodialysis patients [online news]. 5 November 2001 [quoted on November 8, 2001]. Available on the Internet: http://www.baxter.com/utilities/news/releases/2001/11-05dialyzer.html; U.S. Food and Drug Administration. FDA investigating the role of Baxter dialyzers in the deaths of patients on dialysis [online]. 7 November 2001 [quoted on November 8, 2001]. Available online: http://www.fda.gov/cdrh/recalls/dialyzers110701.html; Peterson M, Daly E. Baxter finds possible link between the 53 deaths [online]. NY Times November 6, 2001 [quoted on November 6, 2001]. Available on the Internet: http://www.nytimes.com Check for the receipt of the correction letter and response form dated October 18, 2001 from Baxter. Identify and isolate all affected products from your inventory. Baxter recommends that you suspend the use of all of the above products. Complete and return the answer form by fax 1 (847) 270-5457. If you have distributed these dialyzers to others, please send the correction letter and the response form to them immediately. For more information, please contact your local representative. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257