CareFusion Alaris Pump Module Model 8100: Class I Recall - Motor Stalls During Infusion
MedSun: Newsletter #76, September 2012

FDA Medical Device Safety

FDA notified healthcare professionals and their medical care organizations of the Class I recall of this product due to reports of motor stalls during infusion with the Alaris Pump Module, model 8100. Most of the motor stalls reported have occurred at high infusion rates (typically over 900 ml/hr). The firm cannot rule out the possibility of motor stall occurrence at lower infusion rates. When a motor stall occurs, the Alaris PC unit and the Alaris Pump Module display the visual error code 242.4030 with an audible alarm that is followed by a termination of infusion.

Additional Information:

FDA Medical Device Safety. CareFusion Alaris Pump Module Model 8100: Class I Recall - Motor Stalls During Infusion. August 24, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm316827.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun