FDA Warning for GemStar Infusion Pump Docking Station

FDA Warning for GemStar Infusion Pump Docking StationMay 2, 2014 — Hospira Inc. has issued a Class I recall for the GemStar Docking Station, which is used in conjunction with the GemStar Infusion Pump. The problem is that the GemStar Phase 3 pump may fail to power up when connected to the docking station.

According to the recall notification:

“If the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm and the device will display alarm code 11/003. If a GemStar fails to power up or the 11/003 error code stops an infusion, a delay of therapy may occur. A delay or interruption in therapy has a worst case potential to result in significant injury or death.”

The FDA advises healthcare professionals to carefully weigh the risks and benefits of using this device in critical care. Customers should consider using another pump, especially for patients who could suffer severe injury or death with a delay or interruption in infusion therapy. Hospira does not recommend returning the GemStar Docking Station at this time.

In November 2013, the GemStar Infusion System was recalled because a defective pressure sensor could cause electronic errors that interrupt infusion or over-deliver an infusion, which could potentially cause death. The problem affects models manufactured after January 1, 2009 and products that had a pressure sensor replaced.

Products Affected by GemStar Recall

Impacted/ Affected Product CodeIssuePotential to Occur in Conjunction with Products (Description)Potential to Occur in Conjunction with List Numbers
13075Fail to Power UpGemStar Phase 3 pumps13000, 13100, 13150
Error Code 11/003GemStar Phase 3 pumps or GemStar Phase 4 pumps13000, 13100, 13150 13086, 13087, 13088

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