FDA Provides Update on Baxter’s Recall of Sigma Spectrum Infusion Pump
The FDA has issued an update on Baxter’s Dec. 29, 2021, recall of its SIGMA Spectrum infusion pump and Spectrum IQ infusion system, deeming it a Class 1 recall because of the risk of serious injury or death.
The reason for the recall is the risk that the devices’ alarms may not go off if an occlusion alarm is not fully resolved before restarting the infusion. In such situations, the pump may not re-alarm and may appear to be infusing normally even though it is infusing below the programmed rate or not infusing at all, the agency said.
The recall affected 277,450 products distributed since Feb. 5, 2015.
Baxter has received 51 reports of serious injuries and three reports of patient deaths over five years potentially associated with the problem, the FDA said.