Baxter Recalls SIGMA Infusion Pumps

Baxter Healthcare has recalled its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased false alarm reports of upstream occlusion after pump software upgrades. “False upstream occlusion alarms cause interrupted or delayed therapy and contribute to clinician fatigue, which may cause serious adverse health consequences, especially for people receiving life-sustaining medications,” a recall notice says, adding that use of the affected products may lead to serious injury or death. To date, Baxter says it has received 131 complaints, three serious injuries, and no deaths related to the issue.

The software-controlled infusion pumps are intended to deliver controlled amounts of fluids such as pharmaceuticals, blood and blood products, and other required therapies. The infusion pumps are used in hospitals and other healthcare facilities.