Hospira GemStar Infusion System: Class I Recall
MedSun: Newsletter #90, December 2013

FDA MedWatch Safety Alert

The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test or resulting in an error being reported during device setup or infusion. 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. Customers should immediately perform proximal and distal occlusion tests as defined in the GemStar Technical Service Manual.

Additional Information:

Hospira GemStar Infusion System: Class I Recall. FDA MedWatch Safety Alert. November 25, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376723.htm


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