November 6, 2014 — Hospira Inc. is recalling the GemStar Infusion Pump due to a faulty power supply.
The problem is that the power supply might not deliver electricity, which could cause the GemStar Infusion Pump to fail unless a backup power supply is used. There have been 20 reports of incidents, including one report of the device overheating and smoking.
The FDA believes the problem could cause serious injury or death, though none have been reported. According to the Class I recall:
“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 spark a deadly fire.
In February, Hospira warned customers about the problem and instructed them to avoid arcing, wiggling, or dropping the power supply on hard surfaces to avoid damaging internal components.
The recall affects about 13,000 units globally, including about 5,600 in the United States. The GemStar Wall Mount power supply devices have list number 13026-06 and Desk Top Power Supply have list number 13072-05. They were manufactured and sold from October 2011 through April 2013.
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