FDA Alerts

Class 1 Recall: Hospira Inc., GemStar Infusion System - Pressure Sensor Calibration Drift

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

Fri Mar 15 2013By Kaylee McCaffrey

Product:  Hospira GemStar Infusion System

Models 13000, 13100, 13150, 13086, 13087, 13088

All GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 could be affected.

The pump’s date of manufacture can be found on the Product Identity label located on the back of the pump.

Use: 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.

Recalling Firm:
Hospira Inc.
275 North Field Drive
Lake Forest, Illinois  60045-2579

Reason for Recall:  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.

 

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