Hospira GemStar infusion system pressure sensor calibration drift


#IVTEAM #Intravenous products: FDA report “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 (refer to Recall Notice for list of errors).

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. Potential risks include a delay/interruption in therapy or over-infusion, which have a worst case potential to result in significant injury or death.”

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