U.S. Devices Pulled After 23 Croatian Patients Die

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 Baxter International Inc. of Deerfield, Ill., Prime Minister Ivica Racan said, leading to “suspicion that the filters made by Baxter could have caused these tragic events.”

The state prosecutor and the Interior Ministry were investigating Sunday.

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

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

O’Hayer said all aspects of dialysis--a complex procedure of purifying the blood of patients with ailing kidneys--should be scrutinized. Company officials arrived in Croatia on Sunday to help authorities investigate the deaths.

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

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 analysis of the Croatian solution indicated it was fine.

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

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

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.