BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2448912 · Received February 13, 2012

    Report

    Report Number
    1061932-2012-00381
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: NUCLEATED RED BLOOD CELL MIXING CHAMBER. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A 30 ML BLOOD AND DILUENT LEAK IN THE AIR MIX TEMPERATURE CONTROL (AMTC) AREA OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A PIECE OF RUBBER IN THE NUCLEATED RED BLOOD CELL (NRBC) MIXING CHAMBER, CAUSING OVERFLOW INTO THE BLACK SHIELD AND AROUND THE SPECIMEN TRANSPORT MODULE (STM) MODULE. THE FSE REPLACED THE MIXING CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1