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November 10, 2001

Dialysis Deaths Up in Filter Probe


 (SafetyAlerts) - 

The number of deaths being investigated in connection with Baxter International Inc.'s recalled dialysis filters has grown to 51, including 2 Nebraska kidney patients who died in August.

The U.S. Food and Drug Administration and the Deerfield, Illinois based company said Friday they are reviewing the deaths of patients using 6 models of dialysis filters, which Baxter recalled worldwide last month. Baxter issued a global recall of the filters in mid-October after the reported deaths of about 3 dozen dialysis patients in Europe.

The recall also came after 2 patients died and 2 more were hospitalized in mid-October in Texas during or shortly after dialysis treatments on machines using the Baxter filters at a Capital Dialysis of Texas center in Austin.

In Nebraska, 2 patient deaths at the Overland Trail Dialysis Center in Kearney are being re-examined to see if they could be related to the filters, according to FDA and dialysis center officials.

47 of the deaths happened overseas: 23 in Croatia, 15 in Spain, 7 in Taiwan and 2 in Colombia. The FDA probe is being done with help from the foreign ministries of those countries, who are investigating as well, FDA spokeswoman Sharon Snider said. Croatian government officials already have blamed the filters.

The Baxter recall applies to its Series A and Series AF dialyzers, which were made in Ronneby, Sweden by Althin Medical AB, a company acquired by Baxter last year. The devices help filter waste from the blood of patients with failed kidneys. Baxter has repeatedly said it has found nothing thus far to indicate the filters are at fault and the company has stressed its recall was precautionary.

A company spokeswoman said Baxter expected the number of deaths probed to increase once news spread about the recall and health care professionals reported other deaths of patients who used the equipment. She said the company will investigate every report whether they believe it is related to the equipment or not."

Source: ProMed.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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