Dialysis Filters / BAXTER Mfgr.

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Saturday | October 13, 2001

23 dialysis deaths reported in Croatia

Government halts use of filters made in U.S.

10/15/2001

Associated Press

ZAGREB, Croatia – The government ordered hospitals to stop using dialysis filters made by a U.S. company after 23 patients undergoing treatment with the devices died over six days, the prime minister said Sunday. All the patients who died had received treatment from dialyzers made by the Deerfield-Ill.-based Baxter International Inc., Prime Minister Ivica Racan said, leading to "suspicion that the filters made by Baxter could have caused these tragic events."

The state prosecutor and Interior Ministry were investigating Sunday.

Health Minister Ana Stavljenic Rukavina said that after the Baxter-made dialyzers were replaced with other brands in hospitals on Saturday, no more deaths were reported. Clinics that use dialyzers made by other companies reported no problems with those filters.

During dialysis, patients also receive a solution, and the solution used in Croatian hospitals is made by the Croatian pharmaceutical firm Pliva. Health Ministry officials said the analysis of the Croatian solution indicated it was fine.

Baxter spokeswoman Patty O'Hayer said the "artificial connection" between the deaths and Baxter-made dialyzers had not been substantiated.

She told The Associated Press that all aspects of dialysis – a complex procedure of purifying blood of kidney patients – should be subject to scrutiny. Company officials who arrived in Croatia on Sunday were working with Croatian authorities to investigate the deaths.

A dialyzer is a membrane device that filters waste substances from the blood before it is returned to kidney patients.

The usual death rate for dialysis patients in Croatia is three to six per week, Mr. Rukavina said. About 2,700 patients receive dialysis in Croatian hospitals each year.

Dialyzers made by Baxter were also used in Spain, where 10 kidney patients died in August. An independent investigation found no link between the deaths and the equipment, but the Spanish government said Wednesday that it was waiting for results of its own tests. It was unclear whether identical equipment had been used in Croatia and Spain.