Hospira GemStar Infusion Pump Recalled

November 26, 2013 — Hospira Inc. and the U.S. Food and Drug Administration (FDA) have announced a Class 1 recall of the GemStar Infusion System. All GemStar Infusion Pumps that were manufactured after January 1, 2009, or had a pressure sensor replaced are recalled.

The problem is that the calibration of the pressure sensor can drift, resulting in a electronic error that stops infusion and prevents fluids from reaching a patient. In the worst case scenario, a delay or interruption of therapy could cause significant injury or death to a patient.

The GemStar infusion pump problems can also cause death by over-infusion. According to the FDA:

“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.”

Hospira initiated the recall on March 15, 2013, for Models 13000, 13100, 13150, 13086, 13087, and 13088.

What is the Hospira GemStar Infusion Pump?

Hospira Inc. manufactures the GemStar Infusion System, which is a small, lightweight, single-channeled device that electronically delivers infusions of fluid at a constant rate. The GemStar infusion pump is designed to be used in a hospital, at home, or in an ambulance. It is used to administer intravenous (IV) fluids, medications, nutritional foods, and blood or blood products.

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