Baxter International Inc. has issued a voluntary Urgent Device Correction related to the cleaning practices of the Sigma Spectrum infusion pumps.
A safety alert was originally communicated to customers in April 2020 stating that deviating from the specified cleaning methods may impair pump performance and functionality. Not following the cleaning procedure in the Operator’s Manual can lead to build-up, corrosion, or depression of the electrical pins on the rear case and battery electrical contacts. This could result in issues with the battery causing the pump to shut down without alarming or alerting the user. Any interruption in the intended treatment could end in an adverse event or death.
Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion. The FDA is aware of the notification.
Baxter is recommending customers adhere to the cleaning instructions in the Operator’s Manuals, check the rear case electrical pins and battery electrical contacts for corrosion, build-up or depressed pins, to keep the pump connected to AC power when possible, and to have back-up devices available when infusing critical medications. The company will be updating the Instructions for Use to include looking for signs of build-up, corrosions or depressed pins and will notify customers in writing when available.
Baxter’s full statement including the effected products and contact information on reporting adverse effects is available here.
About the Author
Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.