BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP MEDNET WIRELESS

    MDR report key: 1210923 · Received June 30, 2008

    Report

    Report Number
    2921482-2008-00201
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 4, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    k052052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: USER FACILITY MANDATORY MEDWATCH REPORT. THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH REPORT REC'D THAT STATED: "NURSE PLUGGED PUMP IN. SHE STATED THAT IT IMMEDIATELY SHOCKED HER, AND SHE LET GO OF THE CORD. PRONGS FROM THE AC POWER CORD WERE NOTED TO HAVE SEPARATED FROM THE PLUG AND WERE STILL IN THE WALL OUTLET. PT WAS NOT CONNECTED TO THE PUMP AT THE TIME." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED THE CUSTOMER CONTACT REPORTED A SHOCK. AT 1530, IT WAS REPORTED THAT AS THE NURSE PLUGGED THE DEVICE INTO THE AC POWER OUTLET PRIOR TO CLINICAL USE, THE NURSE'S HAND WAS SHOCKED. THE NURSE DROPPED THE AC POWER CORD, AND NOTED THAT THE PRONGS FROM THE AC PLUG WERE NO LONGER INSIDE THE AC PLUG HOUSING, BUT REMAINED INSIDE THE AC POWER OUTLET. AT 1718, THE NURSE WAS TREATED WITH 2 VICODIN (5MG/500MG) TABLETS IN THE EMERGENCY DEPT FOR REPORTED PAIN AND TENDERNESS TO THE INDEX FINGER. THERE WERE NO REPORTED ADVERSE SEQUELAE TO THE NURSE. AT AN UNSPECIFIED TIME, THE DEVICE WAS REMOVED FROM CLINICAL SVC AND THE AC POWER CORD PRONGS WERE REMOVED FROM THE AC POWER OUTLET. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ PUMP MEDNET WIRELESS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other