November 10, 2001
Dialysis Deaths Up in Filter Probe
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."