BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR BASIC

    MDR report key: 1040375 · Received May 7, 2008

    Report

    Report Number
    1641965-2008-00028
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K902409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: THE REPORTED VOLUMETRIC INACCURACY COULD NOT BE DUPLICATED WHEN TESTED BY QA, SERVICE AND QC. SERVICE STANDARD INSPECTION AND 24-HOUR TESTING FOUND NO FAULTS OR ISSUES WITH THE PUMP.

    Description of Event or Problem · 1

    REPORTEDLY, THE VOLUMETRIC ACCURACY OF THE DEVICE IS OFF. THE FLOW RATES ARE HIGH WHEN USED WITH SMALL SYRINGES. FACILITY CONFIRMED THAT THEY ARE USING BD SYRINGES (3CCS). PUMP WAS SET UP TO DELIVER 6ML/HR, BUT DELIVERED 6.4ML. THE PUMP WAS NOT BEING USED ON A PT AT THE TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1