FDA Provides Update on Safety Problems with Baxter’s Infusion Pumps

The FDA has issued on update on Baxter’s Feb. 17 safety communication about the potential for an alarm malfunction in its Spectrum V8 and Spectrum IQ infusion pumps.

Customers notified the company that the pump “was not delivering medication at the programmed rate displayed on the screen and in some cases was not alarming for upstream occlusions,” the FDA said.

To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may have resulted from incorrect administration setup and/or incomplete resolution of upstream occlusion alarms, the FDA said.

After an occlusion alarm, the healthcare provider must fully resolve the problem before restarting the pump. If that’s not done, the pump may not re-alarm as expected, which can lead to interruption in therapy or under-infusion, the agency said.