BAXTER WITHDRAWS FROM DISTRIBUTION ENTIRE SERIES OF DIALYSER

ZAGREB, Oct 15 (Hina) - The president of the US company Baxter for Central and East Europe, Vincente Belenguer, said in Zagreb Monday that after the unfortunate incidents in Croatia, the company had decided as a precaution to temporarily withdraw from all world markets the A series dialysers containing the same membrane as dialysers used in Croatian hospitals, where 21 kidney patients died after undergoing hemodialysis last week. An independent panel of experts including leading nephrologists has been established and it will collaborate in an investigation into the true cause of the tragic incidents in Croatia, he added. The A series dialysers include dialysers A-15, A-18 and A-22, as well as dialysers P-15 and P-18, which have the membrane made of the same material and which were used until recently in Croatian hospitals, said Baxter's medical equipment deputy director for Europe, Jose Divino. The Croatian Health Ministry believes that the latter two could be responsible for the deaths of 21 kidney patients in the country. After Baxter received reports about the deaths of patients under dialysis in Spain in August, it temporarily withdrew the A-18 dialyser from distribution, and the measure was later cancelled after the "TUV Product Service" company ran tests proving the dialysers were without fault, Divino added. The final results of the probe in Spain are still expected. Speaking about the possibility of claiming responsibility, Belenguer said his company was willing to accept responsibility for the deaths in Croatia if it was proved the Baxter dialysers had caused them, in which case the company would answer under domestic legislation. He also added the company would accept the results of the Croatian investigation and not only those by the independent panel. Of more than a million Baxter dialysers on the market none has ever been connected with any incident, he said. Divino reiterated that the Baxter dialyser was the most frequently tested dialyser in Europe and that it met the ISO 10993 standard, i.e., it was tested according to all relevant factors such as cytotoxicity, system toxicity, skin irritation, and static and dynamic hemolysis. Divino says the investigation, apart from the dialysers, must also include other factors which could have caused the deaths, such as disposable needles, hemodialysis machines, drugs given to patients before and after dialysis, water treatment and dialysis concentrate. Divino admits the current tests may not be sufficiently comprehensive and there could be an unknown factor but he believes that without evidence one should not rush with conclusions. Following the cases in Spain, Baxter has invested thousands of dollars in investigations and will continue doing so, Belenguer said. He said the company's representatives had arrived in Croatia to cooperate with the Croatian authorities, nephrologists and patients and do all in their power to establish the cause of the tragic incidents and not engage in polemics. Baxter International is an international medical corporation. Its headquarters is in Deerfield, Illinois. It employs 45,000 workers and has an annual turnover of USD6.9 billion. The Croatian pharmaceutical company Pliva has been importing Baxter dialysers for 12 years. After last week's deaths, the company has withdrawn all Baxter dialysers from the market. There are currently 2,270 patients treated with hemodialysis in 44 centres in Croatia which use dialysers produced by five different companies. (hina) rml lml