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Croatia Investigates Dialysis Deaths

October 14, 2001

ZAGREB, Croatia (AP) _ The government ordered hospitals to stop using dialysis machines made by a U.S. company after 23 patients undergoing treatment with the equipment died within 48 hours, the prime minister said Sunday.

All the patients who died had received treatment from dialyzers made by the Deerfield-Ill.-based Baxter International Inc., and there were no more deaths once the machines were replaced Saturday afternoon, Prime Minister Ivica Racan said.

The state prosecutor and Interior Ministry were investigating the case Sunday. Racan said the investigation so far ``led to the suspicion that the filters made by Baxter could have caused these tragic events.″

Baxter representatives who arrived in Croatia on Sunday refused to talk to reporters. A Baxter spokeswoman in Deerfield said she had no information about the case but would investigate.

Twenty-three patients were reported dead from hospitals and clinics on Friday and Saturday, Racan told a news conference. Racan turned down an offer by his health minister to resign and called for an investigation ``to find out, urgently, how it could happen and whether there was any way to prevent this tragedy.″

The deputy health minister, Rajko Ostojic, called the numbers ``shocking and unbelievable.″ But he said the ministry has taken all necessary measures and that dialysis patients in Croatia were now ``completely safe.″

The usual death rate for dialysis patients in Croatia is three to six per week, Health Minister Ana Stavljenic 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 it was waiting for results of its own tests. It was unclear whether identical equipment had been used in Croatia and Spain.

Racan said his government had been aware of the Spanish cases, but added that the Croatian importer Pliva had received written guarantees from Baxter that the imported equipment was safe.

Zeljko Covic, head of Pliva, said Baxter delivers the dialyzers in hermetically sealed packages, and added that his firm does not analyze them. A dialyzer is a membrane device that filters waste substances from the blood before it is returned to kidney failure patients.

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