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Product Liability – Defective Medical Device : the FDA just announced a class I recall for the Hospira’s GemStar Infusion because of a pressure sensor calibration drift

hospira_gemstar_fda_recall.jpgAll GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 are being subjected to a FDA Class I recall because of a potential pressure sensor calibration drift.

A calibration drift is a gradual degradation of the sensor and other components that can make readings offset from the original calibrated state. A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. This issue may also result in the pump shutting down.
As a consequence the patient therapy may be delayed or interrupted which may result in significant injury or death.

The GemStar Infusion pump is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. If you are using this device you can check the date of manufacture on the Product Identity label located on the back of the pump.

For more information about the recall read the FDA notice

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