BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATROL PUMP

    MDR report key: 1970357 · Received January 14, 2011

    Report

    Report Number
    1527460-2011-00003
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REDNESS TO THE RIGHT FOREARM. THE TESTING AND INVESTIGATION RESULTS INDICATED THE COMPLAINT FOR SHOCK WAS NOT CONFIRMED. THE PUMP PASSED TWO HIPOT TESTS (ELECTRICAL SAFETY). THE GROUND SCREW WAS TIGHT AND IN THE CORRECT POSITION. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    A NURSE WAS UNPLUGGING THE PUMP TO MOVE IT FROM ONE IV POLE TO ANOTHER IV POLE AND FELT A SHOCK. THERE WAS NO INJURY TO THE PT. THE NURSE'S ARM WAS RED AND SHE WAS TREATED IN THE EMERGENCY ROOM. ADDITIONAL INFO OBTAINED FROM THE RISK MANAGEMENT STATED THAT WHILE UNSCREWING BACK OF TUBE FEEDING PUMP, A SHOCK WAS DELIVERED VIA THE RIGHT HAND. THE NURSE WAS UNABLE TO LET GO OF THE TUBE FEEDING PUMP FOR APPROX FIVE SECONDS. THE FEEDING PUMP WAS PLUGGED INTO A NON-RED OUTLET ON WALL IN ROOM. THE NURSE DID NOT RECEIVE ANY MEDICAL INTERVENTION AND DID NOT MISS ANY WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other