www.fdanews.com/articles/212323-baxter-recall-of-23-000-infusion-pumps-for-false-alarms-now-deemed-class-i

Baxter Recall of 23,000 Infusion Pumps for False Alarms now Deemed Class I

August 3, 2023

Baxter Healthcare’s recall of 23,000 infusion pumps due to repeat upstream occlusion false alarms has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death.

The recalled devices, SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and the Spectrum IQ Infusion System with Dose IQ Safety Software, are software controlled infusion pumps that deliver controlled amounts of fluids such as drugs, blood and blood products and other required therapies.

Baxter is recalling the devices because upgraded software installed on the SIGMA Spectrum and Spectrum IQ infusion pumps “may cause an alarm for an upstream occlusion when there is no actual upstream occlusion present,” Baxter said.

The software that is the subject of this recall was created to address a previous class I recall that presented a risk of these pumps not alarming for repeated upstream occlusion events.

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