Dive Brief:
- Baxter is recalling two of its infusion pumps due to a risk that the devices could give a false alarm for an upstream occlusion, or tubing blockage, interrupting or delaying treatment.
- The company has received 131 complaints and three reports of serious injuries related to the problem, the Food and Drug Administration said in a Tuesday recall notice.
- Clinicians can still use the infusion pumps, but Baxter said they should note that false alarms could occur at a higher rate. The company plans to contact hospitals to revert affected pumps to a previous software version.
Dive Insight:
Baxter’s recall includes its SIGMA Spectrum Infusion Pump with Master Drug Library and its Spectrum IQ Infusion System with Dose IQ Safety Software. The pumps are used in hospitals to deliver drugs, blood and other fluids through infusion.
Baxter started the recall on June 15, and it applies to more than 22,000 devices. The FDA determined the recall was Class I, the most serious risk category, noting that the false alarms could cause serious health consequences, especially for people receiving life-sustaining medications.
The company said clinicians can keep using the devices, and in the meantime, if they are unable to resolve an upstream occlusion alarm, Baxter recommends that they unload and reload the set.
”Our top priority is patient safety and supporting clinicians in providing patient care,” a Baxter spokesperson wrote in an emailed statement. “Baxter has informed all affected customers about this software reversion and is in the process of working with customers to correct this issue on affected Spectrum infusion pumps as soon as possible.”
Baxter said the problem applies to pumps with software versions 8.01.01 and 9.02.01. The current software version was created to address a previous Class I recall when the pump was not alarming for upstream occlusion events. Baxter began that recall last year, and reported 51 injuries and three deaths in a February 2022 FDA notice.