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U.S. firm acts over Croatia deaths

Croatian Health Minister Ana Stavljenic-Rukavina:
Croatian Health Minister Ana Stavljenic-Rukavina: "Something wrong with the filters"  

ZAGREB, Croatia -- A U.S. company has halted distribution of a series of dialysis filters after 23 kidney disease patients receiving treatment died in Croatia last week.

Baxter International is also advising customers to stop using the filters, The Associated Press reports.

An emergency Cabinet session took place in Croatia on Monday following the deaths, most of which occurred on Friday and Saturday in clinics across the country. The deaths are being investigated by the police and state prosecutor.

A team of specialists from the Chicago-based company is to travel to Croatia to help the investigation.

Vicente Belenguer, Baxter's director for eastern and southern Europe, told AP the company's products regularly passed international safety standards.

He said withdrawing the filters from the market was a "precautionary measure," adding: "Patient safety is our priority No. 1."

Belenguer vowed that Baxter would take full responsibility should independent inquiries find that its products caused the deaths.

"We are a responsible company and if the investigations at the end of the day find that Baxter is responsible, we will confront the consequences," he said.

Health authorities said the filters were used in the treatment of all the patients who died and that their investigations indicated that there were no problems with other factors such as water used in the treatment.

Similar claims

Croatian Health Minister Ana Stavljenic-Rukavina said that after the Baxter-made filters were replaced with other brands in hospitals on Saturday, no more deaths were reported.

"It is clear that something was wrong with the filters, but it is unclear what was it at the membrane that caused the clinical symptoms that led to the patients' deaths," she said, according to AP.

In a statement, Baxter the filters were not the only common elements in the treatment of patients who died.

It said one death involved a filter, or dialyser, made by another manufacturer.

The dialyser is a membrane device that filters waste substances from the blood before it is returned to kidney failure patients.

The filters involved are called the P series dialysers or Baxter A series and were distributed by Croatian pharmaceutical company Pliva, Baxter said.

The company faced similar claims in August in Spain after 10 kidney patients died during dialysis, but an independent investigation, carried out by a European quality standards firm, TUV Product Service, found no link between the deaths and the filters.

But the Spanish government said on Wednesday it would run its own tests.

Belenguer said the Baxter dialysers were put under five weeks of "rigorous tests" after the Spanish case, and no fault was discovered.


• Croatia probe into dialysis deaths
October 15, 2001
• Inquiry into 23 dialysis deaths
October 14, 2001

• Croatian government
• Baxter

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