Sigma Infusion Pump Recalled After Thousands of Malfunction Reports

Following thousands of reports of infusion pump system errors and several severe injuries suffered by patients, Baxter is recalling some models of its Sigma Spectrum Infusion Pumps.  

On Wednesday, the FDA determined that a Baxter Sigma Spectrum Infusion Pump recall issued in February should be considered a class I medical device recall, the most serious recall classification. The agency warns that system errors linked to the device can lead to an interruption or delay in therapy, which can pose a risk of serious injuries or death.

Infusion pumps are designed to deliver controlled amounts of fluids that can include medicines, blood, blood products or other vital fluids patients need.

Baxter first notified its customers of the problems with the device in an “Urgent Device Correction” letter sent out on February 7. The company sent out the letter after receiving more than 3,500 reports of a system error that caused at least nine severe adverse events.

According to Baxter, the reports were all from users who say a message indicating a System Error 322 “Link Switch Error (low)” incident. This occurs when the pump improperly detects that the door is open when it is actually closed.

The recall affects Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB. The affected infusion pumps were manufactured from July 1, 2005 through January 15, 2014, and distributed from February 20, 2013 through January 15, 2014.

The devices are used in hospitals, outpatient care, and home care.

Patients with affected infusion pumps should contact their doctor or home care agency. Customers should contact Baxter Healthcare at (800) 356-3454 and choose option 1.

Customers who experience the malfunction are advised to turn the pump off by pressing the ON/OFF key, then turning it back on by pressing the ON/OFF key to clear the alarm. However, clinicians will need to reprogram the infusion pump after restarting it. If the system error does not clear after restarting, the FDA and Baxter recommend that the device be removed from use and sent to the facility’s biomedical engineering department. If the system error persists it should be sent back to Baxter for inspection and service.