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By Davor Huic

ZAGREB (Reuters) – US medical equipment maker Baxter International Inc. said on Wednesday it had recalled some of its blood filters pending results of an investigation into the last week's deaths of 21 kidney dialysis patients in Croatia.

"Our utmost priority is the safety of the patients, this is just a precaution," Jose Divino, associated medical director Europe told Reuters. Divino is on the company team that arrived in Zagreb to assist in the official investigation.

The company recalled three types of dialysers as a precaution after the Croatian ministry of health squarely blamed the product for the spate of deaths during or immediately after treatment in eight local haemodialysis centres.

Deerfield, Illinois-based Baxter invited an independent body–Germany's TuV–to audit its facilities in Sweden and United States. It also set up an independent panel of experts, headed by French nephrologist Bernard Canaud, to conduct its own investigation, which may take several weeks.

"We are fully cooperating with the official investigation," Divino said, adding the company had received assurances from the health ministry it would get access to clinical evidence and other documents on Monday.

"Until the official probe is completed and we are in a position to repeat the tests ourselves, we cannot make any comment about the allegations," Divino said.

He said there was a number of other elements in the process that need to be looked at before making a final judgement.

NO SPANISH LINK?

But a member of the health ministry's investigation team told reporters earlier on Wednesday that they have ruled out all other possible causes of deaths–such as water, the blood lines, needles and medicines used in the treatment.

"They were all different, the only common element in all the cases were Baxter's dialysers," said nephrologist Vladimir Gasparic, admitting however that the precise causal link with the filters has not been established.

"We still don't know the exact mechanism that caused death," he said, adding that the samples of dialysers from the batch used in treatments that ended in fatalities behaved differently from those in the control group."

Gasparic said the autopsies showed some patients had bubbles in their blood, which had caused irreparable damage to lungs or heart and, consequently, sudden death.

But Divino pointed out that this feature makes the Croatian case different from a similar one in Spain this summer, when some 12 kidney patients died, prompting Baxter to withdraw the same type of blood filters from the market.

They reintroduced the product earlier this month, after an independent probe showed there was nothing wrong with them.

Also on Wednesday, Baxter's Croatian partner–the leading drugs firm Pliva, which imports the dialysers and markets them it in Croatia under its name–suspended all commercial relations with Baxter pending the outcome of the investigation