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Twenty-three dialysis patients in Croatian hospitals die; U.S.-made devices pulled

By Ivo Jagatic, Associated Press, 10/14/2001 15:11

ZAGREB, Croatia (AP) 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 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 failure patients.

The first cry of alarm came Friday night from a hospital in Pozega in central Croatia, which reported four deaths, Racan said. Controls with other Croatian hospitals late Friday and through Saturday revealed that 23 patients had died in several clinics, beginning on Monday.

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, 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.

-- Anonymous, October 14, 2001