Dialysis
Filter Recall
Baxter
International Inc., a manufacturer
of blood filters used during dialysis,
has recalled its A, AF, and AX series
blood filters after 31 people died
while undergoing dialysis. Since the
recall, the number of fatalities associated
with the filters has risen to more
than 50.
The
Problem
In
August of this year 10
kidney patients died in Spain
while undergoing dialysis using the
Baxter
dialyzers. As a result of this,
Baxter halted production of its A
series dialyzers and authorities in
France temporarily removed the machines
from nine of its hospitals. Then,
in October, approximately 21 kidney
patients died in Croatia over a period
of one week. Some of the patients
died while undergoing dialysis, while
others died shortly after, with most
of the patients experiencing shortness
of breath, chest tightening, heart
attack, or stroke. Croatian health
officials report that under normal
circumstances, only three to six kidney
patients die per week. Other fatalities
have occurred in Italy, Germany, Taiwan,
Colombia, and the U.S.
The
Response
Baxter International ordered a recall
of all A, AF, and AX series dialyzers
as a precaution. After the deaths
in Croatia, the dialyzers were replaced
and no other deaths have been reported.
At first, Baxter officials claimed
that there was no evidence to suggest
that the dialyzers were to blame for
the deaths and that there were other
common elements that could be responsible
for the fatalities. Now, however,
initial tests have indicated that
a chemical used in the manufacturing
process may have played a role in
the deaths. More research is needed
to confirm this finding. Officials
from Baxter believe that the defective
blood filters, called dialyzers, were
manufactured at a plant in Ronneby,
Sweden. The FDA has launched its own
investigation into the deaths.
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