Baxter withdraws dialysis machinesSep 2, 2001 | AP The United States medical device firm Baxter International Inc has voluntarily recalled two batches of dialysis products in Spain after 15 patients died at health centers while undergoing kidney dialysis.
Baxter, based in the Chicago suburb of Deerfield, Illinois, said today it took the action as a precautionary measure.
Spanish authorities, confirming the recall, said the patients died in the cities of Valencia and Madrid.
The government of Valencia, which runs its own regional health service, is investigating the death of 11 patients at the Virgen el Consuelo hospital, including six this month.
Baxter recalled two batches of the Althane A-18 dialysers, one of the dialysis products used by the centre.
In Madrid, four other people are reported to have died after receiving kidney dialysis treatment, health officials said.
"The patients who died were receiving treatment with different dialysis products and equipment, and some of them were manufactured by Baxter," said Tanya Tyska, spokeswoman for Baxter, today.
"Initial studies conducted by Baxter have shown no malfunctioning of our products and have not revealed any evidence linking a Baxter product to the unfortunate death of these patients," Tyska said. "However, as a precautionary measure, we have instituted a voluntary recall of two batches of our A-18 dialysers."
In dialysis treatment, a person's blood is removed and returned after being filtered for toxic substances.
The government has ordered the Valencia hospital's dialysis department closed while the investigation continues and transferred some 70 patients for treatment at other centres.
So far, the families of two victims have said they plan to take legal action against the hospital.