Sam Brusco, Associate Editor08.01.23
Baxter issued an Urgent Medical Device Correction for its Spectrum V8 and Spectrum IQ infusion pumps in the U.S. and Puerto Rico that were upgraded to software versions v8.01.01 and v9.02.01.
This Urgent Medical Device Correction applies to SIGMA Spectrum Infusion System (V8 Platform) with product code 35700BAX2 and software version v8.01.01 and Spectrum IQ Infusion System with Dose IQ Safety Software with product code 3570009 and software version v9.02.01. The correction was issued because of an increase in reported false upstream occlusion alarms after the software upgrades, and the company said it will be working to revert the software on all affected pumps to the previous version of the software.
The upgraded software, according to Baxter, can cause an alarm for an upstream occlusion when there isn’t an actual upstream occlusion present. The false alarm can cause an interruption or delay in therapy, which can bring about serious adverse health consequences in patients receiving life-sustaining medications.
Baxter has so far received three reports of serious injury related to this issue.
The company said it’s contacting all affected customers to schedule software reversion. Until it’s completed, the false alarms can happen on impacted pumps at a higher rate. Baxter said customers can keep using Spectrum V8 and Spectrum IQ by following on-screen instructions or referencing the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator’s Manual.
If unable to resolve an upstream occlusion alarm, Baxter said customers should unload and reload the set.
This Urgent Medical Device Correction applies to SIGMA Spectrum Infusion System (V8 Platform) with product code 35700BAX2 and software version v8.01.01 and Spectrum IQ Infusion System with Dose IQ Safety Software with product code 3570009 and software version v9.02.01. The correction was issued because of an increase in reported false upstream occlusion alarms after the software upgrades, and the company said it will be working to revert the software on all affected pumps to the previous version of the software.
The upgraded software, according to Baxter, can cause an alarm for an upstream occlusion when there isn’t an actual upstream occlusion present. The false alarm can cause an interruption or delay in therapy, which can bring about serious adverse health consequences in patients receiving life-sustaining medications.
Baxter has so far received three reports of serious injury related to this issue.
The company said it’s contacting all affected customers to schedule software reversion. Until it’s completed, the false alarms can happen on impacted pumps at a higher rate. Baxter said customers can keep using Spectrum V8 and Spectrum IQ by following on-screen instructions or referencing the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator’s Manual.
If unable to resolve an upstream occlusion alarm, Baxter said customers should unload and reload the set.