FDA Alert: Baxter Healthcare Recalls Some COLLEAGUE Infusion Pumps
Baxter Healthcare Corp. and FDA notified healthcare professionals and
consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel
Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.
These electronic infusion pumps are used to deliver controlled amounts
of medications or other fluids to patients through an intravenous (IV),
intra-arterial (IA), epidural, or other direct line into the bloodstream.
The product was recalled because a software irregularity causes the
newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm,
display an error code (16:310:867:0002) and stop the infusion. This occurs
during user programming with all three channels infusing fluids at the same
time.
There are reports of serious injuries that are associated with this
issue. In reported cases, the pump stopped infusing which caused it to activate
an audible and a visual alarm.
Interruption of life-sustaining therapy
could lead to serious injury or death. Remove all the affected triple channel
pumps from service immediately. COLLEAGUE customers with questions should
contact Baxter Medical Delivery Services at 1-800-843-7867.
see also:
FDA Recall News
FDA Recall of Baxter Infusion Pumps--Upgraded COLLEAGUE® ModelsBaxter/FDA Recall of Infusion Pumps Due to Software Malfunction
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