2nd UPDATE: Baxter Finds New Intravenous Pump Problems
11 Março 2009 - 6:35PM
Dow Jones News
Baxter International Inc. (BAX) has found more problems with its
long-troubled "Colleague" intravenous fluid pumps, including
software glitches the company needs to fix and user problems it has
advised customers to avoid.
The Deerfield, Ill., company sent a letter to customers on Jan.
23, a day after its fourth-quarter earnings call, to highlight the
newfound issues with its entire roster of 275,000 Colleague pumps
around the world, including pumps the company issued during
remediation efforts to fix other problems. Colleague pumps were
first pulled in 2005 amid a host of problems and defects linked to
some deaths.
The latest problems came under the spotlight Wednesday when
Baxter said the U.S. Food and Drug Administration had assigned a
"Class 1" recall status to the matter. That is the agency's most
serious recall classification.
Baxter said it doesn't need to pull its pumps from customers,
however, and believes it should be able to fix glitches in the
field. Chief Financial Officer Robert Davis added that the
problems, which involve devices that have recently made a minimal
contribution to sales, won't have a financial impact on the
company. He spoke at a Barclays health-care conference.
Nevertheless, Baxter shares sank $2.77, or 5.4%, to close at
$48.57 on Wednesday.
Colleague pumps are on sale internationally but remain off the
large U.S. market amid a remediation effort that has dragged on
longer than expected. The company left Colleague U.S. sales out of
its 2009 guidance, indicating no expected return this year. Davis
said the latest news doesn't affect the timeline for fixing the
pumps or getting them back on the domestic market.
The pumps posted sales of $170 million in 2004, the last full
year of sales before they were shelved.
At issue currently are three main problems, including a
device-related glitch that prompts failure codes and causes the
pumps to stop delivering medicine and fluids to patients. Baxter is
working on a repair, spokeswoman Erin Gardiner said. The January
letter to customers advised them to use another replacement pump
from inventory if these problems emerge and also included detailed
operating instructions in case a back-up isn't immediately
available.
Two people died after their pumps failed, although the hospitals
in both cases said "they did not believe the subsequent patient
deaths had to do with the pumps," Gardiner said.
Baxter also highlighted two other issues, including the
potential for damaged batteries and for cleaning fluid to cause
short-circuiting and overheating. Both of these are user-related
problems, Baxter determined, that can also be addressed in the
field.
The pumps have batteries for use when patients are being
transported, or during a hospital power outage, but they should be
plugged into an outlet whenever possible. Because the pumps are
electronic devices, they are sensitive to cleaning fluids. In one
case, four health-care workers suffered smoke inhalation from an
improperly cleaned machine, Baxter said.
Though the Colleague pumps are an ongoing issue, they would at
best represent a small portion of sales at Baxter, which also makes
products to address serious problems like immune-system disorders
and kidney failure, and is expected by analysts to post total sales
of about $12.4 billion this year. The recession-induced slowdown in
hospital capital spending may be helping Baxter by keeping
hospitals from seeking out other pump suppliers such as Cardinal
Health Inc. (CAH) and Hospira Inc (HSP).
Cardinal has had its own problems with infusion systems, and it
issued a voluntary safety alert on Tuesday regarding the potential
for improper dosing with certain equipment. The company last month
announced an amended consent decree with the FDA - it has operated
under the decree since early 2007 - that set plans for a detailed
review of infusion pump products.
The new issue involves the "Alaris PC" unit and "Alaris PCA"
module, and not other devices, Cardinal said.
Leerink Swann analyst Rick Wise said in a note that "there are
no easy alternatives for hospitals" despite Baxter's Colleague
issues. He doesn't see any financial impact from the latest
problems and said Wednesday's stock-price slide created a buying
opportunity.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
(Dinah Wisenberg Brin contributed to this article.)