FDA Deems Baxter’s Infusion System Recall Class I

The U.S. Food and Drug Administration has identified Baxter’s late December recall of its SIGMA Spectrum infusion pump (version 8) and Spectrum IQ infusion system with Dose IQ safety software (version 9) as Class I.
 
The infusion systems have been distributed since Feb. 15, and this far 277,450 devices have been recalled in the U.S.
 
The software-controlled infusion pumps deliver controlled doses of pharmaceuticals, blood, blood products, and other therapies. Fluids are administered through an infusion tubing set into the vein or other cleared route.
 
Baxter recalled the infusion systems due to risk of not alarming for repeated upstream occlusion events. After an upstream occlusion alarm, not fully resolving the occlusion before restarting infusion may cause the pump not to re-alarm and appear to be infusing normally. Infusing may in fact be below the programmed rate or not occurring at all. Harm can occur from the interruption or underinfusion.
 
There have thus far been 51 reports of serious injuries and three deaths over five years potentially associated with the issue.
 
Find more information about the recall and instructions here.