Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries.
So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. FDA said the recall involved 306,617 units of the Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 8).
“I’d like to emphasize that this is not a new issue. We alerted customers and FDA to the risks related to improper cleaning of the pumps months ago, and are working on updating the Instructions for Use to provide additional information,” Baxter spokesperson Bess Featherstone told Drug Delivery Business News and MassDevice.
“FDA’s classification of the recall simply comes once the agency completes their risk review. Also, customers can continue to safely use their pumps while following the instructions for cleaning in their Operator’s Manuals,” Featherstone added.
If health providers deviate from cleaning methods described in product-specific operator’s manuals, there could be residue buildup or corrosion of the electrical pins on the infusion pump rear case and battery electrical contacts, Baxter said in its announcement that FDA posted yesterday. Notifications could start popping up that users should check the battery or that batteries are not charging or holding their charge.
Baxter said a corroded Sigma Spectrum infusion pump running solely on battery power could shut down without alerting the user, a potentially deadly situation depending on the type of medication involved and the volume and rate of infusion.
On top of calling for adherence to cleaning instructions, Baxter is asking health providers using the infusion pumps to check the rear case electrical pins and battery electrical contacts for residue buildup or corrosion and depressed pins. The Deerfield, Ill.–based company also recommended other precautions, including having backup devices readily available and keeping the infusion pumps connected to AC power as much as possible.