The recall affects 2 models of Sigma Spectrum Infusion Pumps pumps, manufactured from July 1, 2005, through January 15, 2014. The devices have thus far been associated with 9 "severe adverse events" and more than 3,500 reported failures. There have been no deaths reported thus far, according to the FDA memo.
The devices may experience a "System Error 322," which occurs when the device mistakenly thinks its door is open, possibly causing a delay in therapy. Clinicians must reboot the device to clear the alarm and then reprogram the pump to overcome the defect.
Baxter began warning customers of the issue in February, asking care providers to test their pumps and send back any units that seem remain stuck in alarm mode.
The FDA gave the recall its Class I label, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
It’s not the 1st time the Sigma pumps have been recalled. In November 2013 Baxter issued an Urgent Device Correction warning that the pumps’ upstream occlusion and air-in-line alarms may go off during normal infusion. That recall got the FDA’s lower-risk Class II designation.