November 26, 2013 — The GemStar Infusion System, manufactured by Hospira Inc., is being recalled because a defective pressure sensor may cause electronic errors that result in over-infusion or interruption of infusion therapy, which may cause death.
The U.S. Food and Drug Administration (FDA) announced the recall for all GemStar infusion pumps manufactured after January 1, 2009, and/or pumps that had a pressure sensor replaced during servicing.
The problem is that the pressure sensor calibration can drift, resulting in failure of the pump or an electronic error message. A pump with this problem may not detect an occlusion (blockage) or shut down. In the worst case scenario, a delay or interruption of infusion therapy could cause a patient to suffer a life-threatening injury or death.
The FDA also warns that the GemStar infusion pump may result in over-delivery of an infusion fluid, which could also cause a patient’s death:
“An undetected distal occlusion may cause excessive pressure and fluid build-up within the distal line undetected by the pressure sensor. When the distal occlusion is resolved, the build-up fluid will be administered into the patient possibly causing a maximal over-infusion of 1.0 mL.”
The recall was initiated by Hospira on March 15, 2013, for the following models:
What is the Hospira GemStar Infusion Pump?
The GemStar Infusion System is an infusion pump manufactured by Hospira Inc. It is a small, lightweight, single-channeled electronic device that delivers a constant infusion of fluid to a patient through an intravenous (IV) line. The GemStar infusion pump may be used in an ambulance, home, or hospital to deliver fluids, medications, nutritional foods, and blood/blood products.
Do I have a Hospira GemStar Infusion Pump Lawsuit?
The Schmidt Firm, PLLC is currently accepting Hospira GemStar Infusion System induced injury cases in all 50 states. If you or somebody you know has been injured by a defective GemStar infusion pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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