CareFusion—Model 8100 Alaris Pump Modules: Pump May Stall Intermittently
August 1, 2012 | Strategic Insights for Health System
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In a July 20, 2012, Urgent Medical Device Recall Notification letter submitted by ECRI Institute member hospitals, CareFusion states that it has received reports that the motors of the pump modules below may have stalled intermittently, potentially terminating infusion. CareFusion states that most of the reported motor stalls appear to have occurred at high infusion rates (> 900 mL/hr); however, CareFusion states that the possibility of occurrence at lower infusion rates cannot be ruled out. CareFusion further states that when a motor stall occurs, the PC unit and the above pump modules will display the visual error code 242.4030 and sound an audible alarm, followed by termination of infusion. The error is intermittent, and the repowering of the PC unit may not recover the device every time. CareFusion states that termination of infusion may result in serious patient injury or death.