Hospira recalled its GemStar Power Supply, 3 VDC, because the power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails and a backup power supply is not used, planned infusion therapy may be delayed. 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. In oxygen-rich environments, an electric shock or spark from a malfunctioning pump could cause a fire. 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.
The GemStar Power Supply, 3VDC, is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC. Hospira GemStar Infusion Pumps are used to deliver controlled amounts of fluids including medicines, blood, blood products, nutritional foods, and other mixtures, into a patient’s body in controlled amounts. Hospira Gemstar Infusion Pumps are used in hospitals, for outpatient care, and for home care.
The products impacted by this issue are the GemStar Wall Mount Power Supply-list number 13026-05 and the GemStar Desk Top Power Supply –list number 13072-05. All 13,002 units distributed worldwide, including the 5,687 units distributed in the U.S., may fail.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks