July 21, 2005
Subject: FDA MedWatch - Baxter volumetric infusion pumps:
Recall due to unexpected shutdown causing failure to
deliver medication/fluids
MedWatch - The FDA Safety Information and Adverse
Event Reporting Program
Baxter Healthcare Corporation and 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 are:
Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153,
2M8153R, 2M8163, 2M8163R.
In addition to the shut-down problem, the device
may exhibit two additional failure modes: 1) Users may
inadvertently press the on/off key instead of the start
key when attempting to start an infusion; 2) 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 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.
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