Colleague Volumetric Infusion Pumps
October 13, 2005 (Reuters)
Baxter says FDA seizes nearly 7,000 pumps
Baxter International Inc., which earlier this year stopped shipment of a line
of intravenous pumps to deal with battery issues, on Thursday said U.S.
regulators seized nearly 7,000 of the medical devices.
The U.S. Food and Drug Administration seized about 6,000 Baxter-owned
Colleague Volumetric Infusion Pumps and about 850 Syndeo PCA Syringe Pumps, the
Deerfield, Illinois-based company said.
Baxter, which saw its shares fall nearly 3 percent, said the seizure only
affects its inventory, and not products already on the market. About 250,000
Colleague infusion pumps are currently in use worldwide, including more than
200,000 in the United States, it said. About 5,000 Syndeo pumps, which allow
patients to administer pain analgesics, are in use worldwide.
Baxter said it had placed a voluntary hold on shipments of new Colleague and
Syndeo pumps earlier this year. The Colleague pumps had battery problems, while
the Syndeo pumps had a code issue which caused the pump to stop infusing and
send an alarm as well as a problem with the power button.
Read More...
From MedWatch -
The FDA Safety Information and Adverse Event Reporting Program
Baxter Healthcare Corporation and the FDA notified healthcare professionals of a
Class I 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 models are as follows:
- 2M8151
- 2M8151R
- 2M8161
- 2M8161R
- 2M8153
- 2M8153R
- 2M8163
- 2M8163R
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.
These failures may occur during the infusion of therapy, so it is imperative
that healthcare 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. Read the complete MedWatch 2005
Safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Baxter
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