BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC

    MDR report key: 1040355 · Received May 6, 2008

    Report

    Report Number
    1641965-2008-00026
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Report Date
    April 9, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: THE PUMP MET DELIVERY SPECIFICATIONS WHEN TESTED BY QA AND WHEN FURTHER TESTED BY SERVICE. IN ADDITION, IT WAS DETERMINED BY REVIEW OF THE PUMP'S OPERATION LOG THAT THE PUMP DELIVERED AS PROGRAMMED. REGULAR PREVENTIVE MAINTENANCE AND 24-HOUR RUN-IN TEST WAS PERFORMED. FOUND NO FAULTS OR ISSUES WITH THE PUMP.

    Description of Event or Problem · 1

    REPORTEDLY, THE PUMP DOES NOT INFUSE THE AMOUNT IT SHOWS IT INFUSED. WHEN THE PUMP WAS PROGRAMMED IT TOOK AN HOUR OR TWO LONGER TO DELIVER THAT IT SHOULD HAVE. THERE WAS 400-600CC LEFT IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BASIC INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1