FDA Expands Recall On SIGMA Spectrum Infusion Pump Model 35700
June 19, 2012
Infusion pumps are a vital piece of equipment in medical facilities to deliver fluids, medications, and nutrients to patients by use of a slow drip. However, the Food and Drug Administration (FDA) is considering a certain type of infusion pump a Defective Medical Device due to flow levels being affected by sudden mechanical failure.
According to a press release from the FDA, the SIGMA Spectrum Infusion Pump Model 35700 can stop working at any moment, causing flow levels to fluctuate between completely blocked and free flowing with no alarm sounding. This could cause serious injury or death to a patient.
Although the original recall was issued on September 15, 2010, for serial numbers on the units ranging from 706497 to 724065, the recall was updated this past Friday to include all serial numbers ranging from 700000 to 794213.
Officials say that the use of these pumps should be halted immediately. SIGMA should then be contacted in order to have the unit serviced or replaced.
Any adverse events resulting from use of the infusion pumps should be reported to the FDA’s MedWatch program immediately.
The Drug Injury Lawyers with Ferrer, Poirot & Wansbrough understand the adverse effects that failure of an infusion pump could have on patients, from not receiving medications at all to overdoses. That is why they suggest contacting an experienced attorney if you have suffered an injury because of a defective medical device.