Baxter recalls infusion pumps
Baxter Healthcare Corp. in Deerfield, IL, is recalling all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering 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, and 2M8163R. This is a Class-I recall, which is the most serious type of recall that involve situations in which there is a reasonable probability that the use of the affected product will cause serious injury or death.
Baxter also advised customers March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, or 599 related to the electronic problems. It also advised customers to stop using any pumps that show 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 shutdown problem, the device may exhibit two additional failure modes: Users inadvertently might press on/off key instead of start key when attempting to start an infusion. Also, disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, which requires the infusion to restart.
At this time, users should not return the pumps to Baxter. The company’s letters to customers are available on its web site (www.Baxter.com). Under "recent links," click on "NEWS: Baxter Receives Notice from FDA Classifying Colleague Infusion Pump March 2005 Corrective Action as a Class I Recall." Click hyperlinks for letters at the bottom of that notice.