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Baxter
Urges Comprehensive Scientific Analysis of Hemodialysis Treatment Safety
Baxter Establishes
Independent Expert Panel of Nephrologists
to Ensure Patient Safety
Panel to Cooperate Fully with
Authorities in Comprehensive Investigation of all Aspects of the Therapy
Deerfield, Illinois, USA and Zagreb, Croatia (15 October 2001) - Following
notification of 23 deaths involving patients in eight hemodialysis centers
over the weekend in Croatia, Baxter International Inc.'s European subsidiary
immediately dispatched a specialist team to work with the authorities
to investigate the cause(s) of these unfortunate incidents.
"It is nearly impossible at this early point in time to identify
with any certainty the causes of these patient deaths since there are
many variables involved in these incidents," said Dr. Jose Divino,
associate medical director of Baxter's Dialysis Business in Europe, who
led the Baxter team dispatched to Croatia over the weekend when the deaths
were first reported. "According to the initial reports we've received,
we understand the autopsies showed differing causes of death and little
consistency in the timing of the onset of symptoms."
The different lots and models of the Pliva-distributed P series of dialyzer
(also known as the Baxter A series) used in 22 of 23 of these cases --
one incident involved a dialyzer by another manufacturer -- were not the
only common elements in the treatment.
"Patient safety is our highest priority," said Dr. Divino in
an interview with Croatian TV Sunday night. "That is why we feel
it is critical that all aspects of the hemodialysis treatment be thoroughly
investigated."
No element of the dialysis treatment has undergone as extensive testing
as this series of dialyzers. TÜV Product Service GmbH (the leading
independent European authority of the safety of medical devices and specifically
hemodialysis equipment) released its independent report on Tuesday, October
9, 2001, which provided irrefutable evidence supporting the safety of
Baxter's dialyzer. This confirms the four separate internal tests conducted
by Baxter, following recent deaths in Spain. Baxter and TÜV conducted
the testing according to the most rigorous and intensive standard for
testing biocompatibility in medical devices, called ISO 10993. The tests
took more than four weeks and included cytotoxicity, intracutaneous reactivity,
systemic toxicity and hemolysis (dynamic and static).
All testing by Baxter, as well as independent testing by TÜV Product
Service, has continued to demonstrate the safety of these dialyzers. Nevertheless,
in an abundance of caution, Baxter has put a global hold on distribution
of this series of dialyzers and is advising customers worldwide to temporarily
discontinue use, pending the evaluation by an expert commission. Baxter
will work with customers to find suitable alternative dialyzers to use
in the interim.
Today, Baxter established an independent panel of recognized experts in
nephrology to cooperate fully with all authorities in the comprehensive
investigation of these dialysis incidents. The expert team will be led
by Professor Bernard Canaud from Montpelier, France. The remaining members
of this newly appointed commission are affiliated with several major European
university hospitals and TÜV Product Service.
Baxter International Inc. is a global medical products and services company
that, through its subsidiaries, provides critical therapies for people
with life-threatening conditions. Baxter's products and services in the
areas of bioscience (including biopharmaceuticals, vaccines, biosurgery
products and transfusion therapies), medication delivery and renal therapy
are used by health-care providers and their patients in more than 100
countries.
FOR ADDITIONAL
INFORMATION:
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- Media Contacts:
- Dubravko
Miholiæ, Hauska&Partner, Zagreb, GSM: +385.091 315 8282,
or
Frank
Butschbacher, Baxter, GSM: +49.172.6200822
- Sally Benjamin
Young, Baxter, U.S., (847) 948-2304
Lisa Scheff, Baxter, U.S. (847) 948-4107
Deborah Spak, Baxter, U.S. (847) 948-2349
- Investor Contacts:
- Neville
Jeharajah, (847)948-2875
Mary Kay Ladone, (847) 948-3371
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