BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN/MCGAW 360 INFUSER

    MDR report key: 1173030 · Received September 19, 2008

    Report

    Report Number
    1641965-2008-00071
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    August 25, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K902409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: B. BRAUN SERVICE COULD NOT DUPLICATE THE REPORTED INCIDENT. STANDARD INSPECTION AND 24-HOUR TESTING FOUND NO FAULTS OR ISSUES WITH THE PUMP.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE TAKES TOO LONG TO INFUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B. BRAUN/MCGAW 360 INFUSER SYRINGE PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1