Company: Hospira Inc
Date of Enforcement Report: 11/25/2013
Class l:

PRODUCT

Hospira GemStar Infusion System
Models 13000, 13100, 13150, 13086, 13087, 13088
The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products. The device can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, the GemStar Pump is used for ambulatory patients.

REASON
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion:

Cassette Check ? D
Cassette Check – P
Proximal Occlusion
Distal Occlusion
Pressure Calibration Error
Bad Pressure Sensor Event
Bad Pressure Sensor State
Distal Pressure is Out of Range
Proximal Sensor is Out of Range
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.

RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IllinoiI on 3/15/2013. Voluntary: Firm Initiated recall is ongoing.

FDA District
Chicago District Office

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