BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRATHERM

    MDR report key: 852960 · Received May 10, 2007

    Report

    Report Number
    MW1042844
    Event Type
    Other
    Date Received
    May 10, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 1, 2007
    Manufacturer
    GAMBRO
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AREA OF CONCERN: METHOD(S) FOR CONNECTING SPECTRA THERM TUBING SET TO SPECTRA BLOOD TUBING SET. THE MANUFACTURER'S INSTRUCTION MANUAL RECOMMENDS 4 CONNECTING METHODS (A-D). WE HAVE FOUND THAT USING METHOD A- CAN RESULT IN GREATER POSSIBILITY OF INTRODUCING UNDETECTED AIR IN THE TUBING SET IF TUBING IS NOT PRIMED CORRECTLY AND OR NEEDLE BECOMES DISLODGED. METHOD C - HAS PROVEN TO BE SAFER AND MORE OPTIMAL FOR PATIENTS WITHOUT PRESENTING RISK OF UNDETECTED AIR IN TUBING AND LESS CHANCE FOR HUMAN ERROR. THEREFORE, WE ARE RECOMMENDING THAT THE MANUFACTURER PRIMARILY ADVOCATES USE OF METHOD C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRATHERM BLOOD/FLUID WARMER SET BRZ GAMBRO * 508471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other