The U.S. Food and Drug Administration issued a class 1 recall of the Sigma Spectrum Infusion Pump, noting that it can fail without warning, potentially causing serious injury or death.

The agency issued the recall, its most serious, as the units can suddenly cause "inaccurate flow conditions during use, ranging from back flow to over-infusion," the agency said. The FDA said the pump does not sound an alarm when this happens.

Sigma International General Medical Apparatus, LLC of Medina N.Y., which makes the pumps, warned customers of the problem on September 15. The company asks customers to return all affected devices, SIGMA Spectrum Infusion Pump Model 35700 made between October 2006 to March 2008.
Infusion pumps, which deliver drugs, blood, fluids and liquid food, are prone to malfunctions. According to the FDA's Center for Devices and Radiological Health, there have been 56,000 reports of pump error and 87 recalls between 2005 and 2009.

There have also been 710 reported deaths, although the director of the CDRH, Dr. Jeffrey Shuren, said that figure is likely an underestimate as most deaths from the devices aren't reported as caused by device error.

In April, the FDA launched a new safety initiative to prevent pump malfunctions. The following month, it ordered Baxter Healthcare to recall and destroy thousands of Colleague Volumetric Infusion Pumps after numerous reports of errors.

More Industry Headlines