DEERFIELD, Ill., July 28, 2023 – Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in the U.S. and Puerto Rico that have been upgraded to software versions v8.01.01 and v9.02.01. The Correction is due to an increase in reported false upstream occlusion alarms following the software upgrades. Baxter will be working with customers to revert the software on all affected pumps to the previous software version.
The upgraded software installed on Spectrum V8 and Spectrum IQ infusion pumps may cause an alarm for an upstream occlusion when there is no actual upstream occlusion present. This false alarm may lead to an interruption or delay of therapy. An interruption or delay of therapy may cause serious adverse health consequences in patients who are receiving life-sustaining medications. Baxter has received three reports of serious injury potentially associated with this issue.
