Baxter Infusion Pumps Hit with Another Class I Recall

Baxter Healthcare has once again found itself in the depths of a Class I recall for its infusion pump systems.

Recently announcing the recall, the company reported that its Sigma Spectrum Infusion Pump with Master Drug Library (version eight) and Spectrum IQ Infusion System with Dose IQ Safety Software (version nine) are seeing increased false alarms for upstream occlusion after upgrading the software to version v8.01.01 and v9.02.01, respectively.

Both infusion pump systems deliver controlled amounts of fluids to patients into a vein or other cleared route, including pharmaceutical drugs, blood and blood products, among other required therapies. The pumps are used in hospitals and healthcare facilities.

The recall stated the company has received 131 complaints, three serious injuries, and no deaths related to the issue. False upstream occlusion alarms can cause interrupted or delayed therapy leading to serious adverse health consequences and contribute to clinician fatigue. Currently there’s been 22,769 recalled pumps in the US with the distribution dates of Sept. 29, 2015, to May 2, 2023.

The software versions named in the current recall were created to address a previous Class I recall for versions v8.01.00 and v9.02.00 which detailed pumps with the opposite issue — not alarming for repeated upstream occlusion events. Initially sending customers an Urgent Medical Device Correction letter on June 15, Baxter recommended continuing use of the two pumps and following on-screen instructions or infusion setup instructions in the operator’s manual, including sections: Preparing the Pump and IV Sets; Programming the Pump; and Alarms: Upstream Occlusion Alarm Troubleshooting. Additionally, the company highlighted that until a software reversion is completed, there could be a higher rate of false upstream occlusion alarms. It a clinician is unable to resolve an upstream occlusion alarm, Baxter recommended to unload and reload the set.

In the recall notice, Baxter said it is working to fix the issue and representatives will contact facilities to determine a correction plan, scheduling a no charge software reversion for all affected pumps to the previous eight and nine versions, respectively. The previous versions, however, still present with the issue of not alarming for repeated upstream occlusion events.

"Our top priority is patient safety and supporting clinicians in providing patient care," a spokesperson from Baxter told MD+DI. "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."