BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC

    MDR report key: 1231107 · Received November 11, 2008

    Report

    Report Number
    1641965-2008-00081
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL RESULTS: THE PUMP WAS INOPERABLE WHEN RECEIVED DUE TO A DAMAGED AIR-IN-LINE SENSOR; THEREFORE, THE INITIAL DELIVERY RATE TESTING COULD NOT BE PERFORMED. THE AIR-IN-LINE SENSOR WAS REPLACED AND THE PUMP MET DELIVERY SPECIFICATIONS. THE PUMP WAS MOST RECENTLY RETURNED FOR REPAIR IN 2008. THE DAMAGE TO THE AIR-IN-LINE SENSOR WAS DUE TO USER MISHANDLING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PUMP WAS UNDERINFUSING BY HALF. CUSTOMER STATED THAT IF THEY SET RATE TO 200, ONLY 100 GOES THROUGH. IF THEY RESET RATE FOR THE REMAINING 100, THEN ONLY 50 GOES THROUGH.

    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