Baxter Pump
Baxter Healthcare
Corporation and FDA notified healthcare professionals of a Class I recall of all
models of its Colleague Volumetric Infusion Pumps. These pumps 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
shutdown problem.
The affected models are:
- 2M8151
- 2M8151R
- 2M8161
- 2M8161R
- 2M8153
- 2M8153R
- 2M8163
- 2M8163R.
In addition to the shutdown
problem, the device may exhibit two additional failures
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.
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