Fresenius Kabi Pump Early Alert

FDA has issued an early alert for an infusion pump issue from Fresenius Kabi USA. It is the first alert issued under a new CDRH communications pilot intended to enhance the medical device recall program.

The early alert says the agency is aware that the company has issued a letter to affected healthcare providers indicating that a subset of Ivenix large-volume pumps are to be removed from use for repair. It says Fresenius reports that a subset of pneumatic valves installed on some of the Ivenix pumps has an increased chance of issuing a non-recoverable pump problem alarm. The firm has not reported any injuries or deaths associated with the issue, FDA says.

CDRH says the new early alert pilot program will provide information on potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. There currently is no change to any other recall process or recall communications timelines for other areas, it says.