BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL3M PUMP

    MDR report key: 1241685 · Received November 19, 2008

    Report

    Report Number
    2921482-2008-00381
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 21, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RECEIVED WITHOUT THE BATTERY. TESTING AND INVESTIGATION FOUND THE DEVICE PASSED ELECTRICAL SAFETY TESTING USING A TEST BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SPARK. THE CUSTOMER CONTACT STATED THAT WHILE PLACING THE BATTERY, A SPARK WAS NOTED FROM THE BATTERY CONNECTOR. THERE WAS NO ADVERSE EFFECTS TO THE HEALTHCARE PROFESSIONAL. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL3M PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1