Sigma Spectrum Infusion Pump Recall: Risk of Drug Overdose

Federal regulators have announced another infusion pump recall, this time involving the Sigma Spectrum infusion pump, which may fail and potentially deliver a fatal drug overdose without setting off an alarm to alert doctors.

Earlier this year, the FDA announced a new initiative to address safety problems with infusion pumps, which have been linked to more than 56,000 adverse event reports over the past five years, including at least 500 deaths. According to FDA data, there were 87 infusion pump recalls between 2005 and 2009 to address identified safety concerns.

The Sigma Spectrum pump recall was announced by the FDA on November 12, after the manufacturer, Sigma International, found that the units can fail suddenly. If the units fail, they could cause too little or too much medication to flow into the patient without healthcare professionals knowing about it.

The FDA has classified the infusion pump recall as a Class I medical device recall, meaning that the FDA believes that the device’s defect is likely to cause severe injury or death. However, there were no reports of injuries or deaths announced at the time of the recall.

The recall affects the SIGMA Spectrum Infusion Pump Model 35700. The recalled units have serial numbers ranging from 706497 to 724065. The units were manufactured from October 2006 through March 2008.

The company has informed customers by letter about the recall. They are being asked to return the pumps to the company, which will repair or replace them.