Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S.
Affected pumps in the U.S. and Puerto Rico received upgrades to software versions v8.01.01 and v9.02.01. Baxter issued the correction due to an increase in reported false upstream occlusion alarms following the software upgrades. The Deerfield, Illinois-based company plans to revert the software to the previous version on all affected pumps.
Baxter’s notice said that the upgraded software may cause an alarm for upstream occlusion when one isn’t present. That can lead to an interruption or delay of therapy, potentially causing serious adverse health consequences for users.
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