FDA recall: GemStar infusion pump power supply failure


FDA report “The power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. Hospira received a total of 20 reported incidents including one report of smoke and found that the GemStar Infusion Pump was operating on battery power while connected to the 3VDC power supply. There were no reports of injuries or death.

The firm noted that all 13,002 units distributed worldwide, with 5,687 of those units distributed in the U.S., may fail. The use of the recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death. In oxygen-rich environments, an electric shock or spark from a malfunctioning pump could cause a fire.”


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