FDA: Class I recall of certain Baxter infusion pumps, systems

Editor's Note

The Food and Drug Administration (FDA), on March 11, designated the recall by Baxter of its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) as Class I, the most serious.

The recall was initiated because of the risk of not alarming for repeated upstream occlusion events. If an occlusion is not fully resolved before restarting infusion, the pump may not alarm as expected and may appear to be infusing normally, even though it’s not.

Baxter has received 51 reports of serious injuries and 3 reports of patient deaths over 5 years that may potentially be associated with this issue.

Distribution dates were February 5, 2015 to present.