Baxter Infusion Pump Attorneys
FDA Announces Class I Recall of Baxter Healthcare's
Colleague Volumetric Infusion Pumps - July 21, 2005
The U.S. Food and Drug Administration (FDA) is announcing that Baxter
Healthcare Corporation of Deerfield, Ill., has initiated a worldwide recall
of all models of its Colleague Volumetric Infusion Pumps because they
can shut down while delivering critical medication and fluids to patients.
Baxter has received six reports of serious injury and three reports of
death associated with this shut-down problem. The affected are: Models
2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
Based on information from a current FDA inspection and independent analysis
of the failure modes by FDA's Office of Science and Engineering Laboratories,
as well as a comprehensive review of adverse event reports in FDA's database,
FDA has determined that this action is a Class I recall. Class I recalls
are the most serious type of recall and involve situations in which there
is a reasonable probability that use of the affected product will cause
serious injury or death.
"Given the widespread use of these pumps and the multiple failure
modes, FDA is quickly informing users of this important safety issue,"
said Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological
Health. "We will continue to monitor the situation closely and inform
the public immediately of any new developments."
The firm notified customers today that it has voluntarily stopped shipping
Colleague Volumetric Infusion Pumps until the problems are resolved. Baxter
also advised customers on March 15, 2005, to stop using any pumps that
exhibit a failure code beginning with 402, 403, 533, 535, or 599, related
to these electronic problems. Additionally, Baxter advised customers to
take out of service any pumps that exhibit failure codes 810:04 and 810:11
related to air-in-line sensor problems, until they are inspected by authorized
service personnel.
In addition to the shut-down problem, the device may exhibit two additional
failure modes:
Users may inadvertently press the on/off key instead of the start key
when attempting to start an infusion.
Disconnecting or connecting the pump from the hospital monitoring system
while the pump is powered "on" can result in a failure code,
requiring the infusion to be restarted.
Also, these failures may occur during the infusion of therapy, so it is
imperative that health care institutions have a contingency plan to mitigate
any disruptions of infusions of life-sustaining drugs or fluids.
Approximately 255,000 Colleague Volumetric Infusion Pumps are currently
in use, including 206,000 distributed in the United States. They have
been sold to physicians, hospitals, pharmacies, and a variety of other
medical facilities.
At this time, users should not return the pumps to Baxter.
Baxter's letters to customers are available on its web site at www.Baxter.com.
Consumers who have questions about the recall may contact Baxter Healthcare
at 1-800-422-9837. Those who have technical questions may contact Baxter
Healthcare at 1-800-THE-PUMP (800-843-7867).
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