Baxter Infusion Pumps Recalled Over MalfunctionMay 2, 2014
Baxter Healthcare Corp has recalled some models of its Sigma Spectrum Infusion Pumps, after receiving more than 3,500 reports of malfunctions, the U.S. Food and Drug Administration (FDA) said.
The recall is a Class 1 recall, the FDA’s most serious category, which indicates there is a probability that use of the product will cause serious health problems or death, Reuters reports. The recalled pumps were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.
Infusion pumps deliver controlled amounts of intravenous fluids including medicines, blood, blood products and other mixtures, through a vein or an artery, under the skin, into the spine, or by other acceptable routes, according to the FDA. The Sigma Spectrum Infusion Pumps with Master Drug Library are used in hospitals, outpatient care, and home care.
The recall was undertaken in response to reports of System Error 322 “Link Switch Error (low)” incidents in which the pump malfunctioned. Nine of the reports were for severe adverse events but no deaths were reported. A System Error 322 occurs when the pump improperly detects that the door is open when it is actually closed. A System Error 322 can lead to an interruption or delay in therapy, the FDA says. When a System Error 322 occurs, a clinician must reset the alarm, reprogram the pump, and confirm the infusion is running properly.
Baxter asked customers who encountered a System Error 322 to:
1. Turn the pump off by pressing the ON/OFF Key, then
2. Turn the pump back on by pressing the ON/OFF key in order to clear the alarm. If the alarm cannot be cleared, the device should be removed from use and sent to a biomedical engineering department. If the malfunction reoccurs, the pump may need inspection and service by Baxter Healthcare Corporation, the FDA advises.
Affected customers can contact Baxter Healthcare at 1.800.356.3454, Monday through Friday, 7 a.m. to 7 p.m., Eastern Time. To report an adverse event to the FDA MedWatch Safety Information and Adverse Event Reporting Program, go to www.fda.gov/MedWatch/report.htm.