BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLMD PUMP

    MDR report key: 1002613 · Received February 8, 2008

    Report

    Report Number
    2921482-2008-00048
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 10, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE, TESTING COULD NOT BE PERFORMED FOR THE REPORTED EVENT OF AIR WAS NOTED DISTAL TO THE CASSETTE WITH NO DEVICE ALARM. THE DEVICE WOULD NOT POWER ON USING AC OR DC POWER. REPAIRING THE DEVICE WOULD AFFECT TESTING RESULTS; THEREFORE, FURTHER TESTING COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, AIR WAS NOTED DISTAL TO THE CASSETTE WITH NO DEVICE ALARM. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA