Baxter issues urgent device correction to reinforce important safety information regarding cleaning practices of all Sigma Spectrum infusion pumps

Baxter International has issued an Urgent Device Correction to highlight key safety information for cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean. Deviations from the specified cleaning methods could affect infusion pump functionality and performance, the company said. Baxter previously communicated this information directly to customers in a safety alert in April 2020 and then in an Urgent Device Correction notification in August. According to Baxter, deviations from the cleaning methods detailed in product-specific operator’s manuals could lead to residue buildup or corrosion of the electrical pins on the infusion pump rear case and battery electrical contacts. If there is buildup or corrosion, and the device is running only on battery power, the pump may shut off without alerting the user, which could lead to a delay or interruption of intended treatment. The company says it has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion.