The FDA later issued a notice identifying the recall as Class I, the most serious kind. Baxter recalled 22,769 devices in total.
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.
Baxter received three reports of serious injury potentially associated with the issue and no deaths. It received 131 complaints in total, according to the FDA notice.
The company said it intends to contact all affected customers to schedule the software reversion. Until completed, false upstream occlusion alarms can occur on impacted pumps at a higher rate.
Customers can continue using affected pumps by following on-screen instructions. They can also reference the operator’s manual. If a customer fails to resolve an upstream occlusion alarm, they should unload and reload the set.
Baxter’s medical device correction applies to Spectrum V8 (product code 35700BAX2 software version v8.01.01) and Spectrum IQ with Dose IQ safety software (product code 3570009 and software version v9.02.01).
