Cleaning Method Deviations Could Impair Sigma Pump: Baxter

FDA says Baxter has issued an urgent device correction to reinforce safety information on cleaning practices for all Sigma Spectrum infusion pumps. The 10/28 notice says that deviations from the specified cleaning methods may impair infusion pump functionality and performance. The company says it communicated the information to customers in a 4/1 safety alert and 8/28 urgent device correction notification.

According to Baxter, deviations from the cleaning methods described in product-specific operator’s manuals may lead to residue buildup or corrosion of the electrical pins on the infusion pump rear case and battery electrical contacts. That could result in notifications that the user should check the battery or that batteries are not charging or holding their charge, it says.

The notice says that to date Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion.