CHICAGO (AP) _ Baxter International Inc. said Monday that its dialysis filters appear to have played a role in the recent deaths of dialysis patients in several countries.
The company's announcement came with health authorities investigating the deaths of 51 patients in connection with Baxter's dialysis filters _ two each in Nebraska and Texas the rest overseas.
The Food and Drug Administration and the Deerfield, Ill.-based company have been reviewing the deaths of patients using six models of dialysis filters, which Baxter recalled worldwide in mid-October after the deaths of about three dozen dialysis patients in Europe were reported.
Baxter said it concluded from preliminary tests completed over the weekend that a processing fluid used in its manufacturing operation in Ronneby, Sweden, may have played a role in many of the deaths. It is discontinuing production of the systems made there.
Harry Jansen Kraemer Jr., Baxter's chairman and chief executive, said the company is ``greatly saddened'' by the deaths and has a responsibility to swiftly make its findings public.
The company's Series A and Series AF dialyzers were made in Sweden by Althin Medical AB, a company acquired by Baxter last year. The dialyzers help filter waste from the blood of patients with failed kidneys.
``While a small number of our A and AF dialyzers appear to have played a role in some of these tragic events, we believe there remain substantive gaps in information about the facts associated with many of the patient deaths,'' he said. ``Therefore, we have decided that in the interest of patient safety, the most prudent course of action is to permanently cease manufacturing these dialyzers.''
Baxter said it expects to take a charge of $100 million to $150 million in the fourth quarter to cover the cost of discontinuing the products and other related costs.