Baxter recalled over 277,000 infusion pumps due to the risk of the device failing to alarm users of repeated upstream occlusion events.
The SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) are software-controlled infusion pumps that deliver controlled amounts of fluids to users, according to the March 11 FDA recall notice.
If an occlusion is not fully resolved before restarting the infusion, the pump may not re-alarm as expected and may appear to be infusing normally, which can cause harm from interruption in therapy and/or underinfusion.
Baxter said it has received 51 reports of serious injuries and three reports of patient deaths possibly linked to the issue over five years.