BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2352115 · Received November 29, 2011

    Report

    Report Number
    1061932-2011-02478
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    October 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VACUUM CHAMBER. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE DIFFERENTIAL AND NUCLEATED RED BLOOD CELL (NRBC) CHAMBER WERE NOT DRAINING ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. CUSTOMER REPORTED THAT PROBABLY CORING WAS BLOCKING THE DRAIN PORT. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE VC350 (MAIN VACUUM CHAMBER) WAS PLUGGED AT PORT 7, CAUSING THE DIFFERENTIAL AND NRBC CHAMBERS TO NOT DRAIN. THE PLUG ALSO RESULTED IN PRESSURE BUILDUP IN CHAMBER VC115 (COMPLETE BLOOD COUNT WASTE CHAMBER) WHICH PREVENTED VC199 (VENT CHAMBER) FROM DRAINING. PRESSURE INTRODUCED INTO PORT 1 OF VC199 CAUSED FLUID TO SPRAY OUT OF THE OPEN PORTS, DAMAGING THE COMPLETE BLOOD COUNT (CBC) WASTE INTERFACE BOARD, FURTHER CAUSING DAMAGE TO THE CABLE AND SOLENOID EXPANSION BOARD 2. THE FSE CLEARED THE OBSTRUCTION AND REPLACED THE CBC WASTE BOARD, CABLE, AND SOLENOID EXPANSION BOARD 2.

    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