Baxter Urges Comprehensive Scientific Analysis of Hemodialysis Treatment Safety * Baxter Establishes Independent Expert Panel of Nephrologists to Ensure Patient
16.10.2001, 10:58
DEERFIELD (Illinois, USA) / ZAGREB, Oct 16 (PROTEXT/APA-ots)- Following notification of 23 deaths involving patients in eighthemodialysis centers over the weekend in Croatia, BaxterInternational Inc.'s European subsidiary immediately dispatched aspecialist team to work with the authorities to investigate thecause(s) of these unfortunate incidents.
"It is nearly impossible at this early point in time toidentify with any certainty the causes of these patient deathssince there are many variables involved in these incidents," saidDr. Jose Divino, associate medical director of Baxter's DialysisBusiness in Europe, who led the Baxter team dispatched to Croatiaover the weekend when the deaths were first reported. "Accordingto the initial reports we've received, we understand theautopsies showed differing causes of death and little consistencyin the timing of the onset of symptoms."
The different lots and models of the Pliva-distributed Pseries of dialyzer (also known as the Baxter A series) used in 22of 23 of these cases - one incident involved a dialyzer byanother manufacturer - were not the only common elements in thetreatment.
"Patient safety is our highest priority," said Dr. Divino inan interview with Croatian TV Sunday night. "That is why we feelit is critical that all aspects of the hemodialysis treatment bethoroughly investigated."
No element of the dialysis treatment has undergone asextensive testing as this series of dialyzers. TÜV ProductService GmbH (the leading independent European authority of thesafety of medical devices and specifically hemodialysisequipment) released its independent report on Tuesday, October 9,2001, which provided irrefutable evidence supporting the safetyof Baxter's dialyzer. This confirms the four separate internaltests conducted by Baxter, following recent deaths in Spain.Baxter and TÜV conducted the testing according to the mostrigorous and intensive standard for testing biocompatibility inmedical devices, called ISO 10993. The tests took more than fourweeks and included cytotoxicity, intracutaneous reactivity,systemic toxicity and hemolysis (dynamic and static).
All testing by Baxter, as well as independent testing by TÜVProduct Service, has continued to demonstrate the safety of thesedialyzers. Nevertheless, in an abundance of caution, Baxter hasput a global hold on distribution of this series of dialyzers andis temporarily advising customers worldwide to temporarilydiscontinue use, pending the evaluation by an expert commission.Baxter will work with customers to find suitable alternativedialyzers to use in the interim.
Today, Baxter established an independent panel of recognizedexperts in nephrology to cooperate fully with all authorities inthe comprehensive investigation of these dialysis incidents. Theexpert team will be led by Professor Bernard Canaud fromMontpelier, France. The remaining members of this newlyappointed commission are affiliated with several major EuropeanUniversity Hospitals and TÜV Product Service.
Baxter International Inc. is a global medical products andservices company that, through its subsidiaries, providescritical therapies for people with life-threatening conditions.Baxter's products and services in the areas of bioscience(including biopharmaceuticals, vaccines, biosurgery products andtransfusion therapies), medication delivery and renal therapy areused by health-care providers and their patients in more than 100countries.For media contacts please call:Patricia O'Hayer, Baxter, GSM:+32. 476855462Frank Butschbacher, Baxter, GSM: +49.172.6200822
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