BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3151029 · Received June 6, 2013

    Report

    Report Number
    1061932-2013-01016
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND NOTICED EVIDENCE OF A DRIED LEAK ON THE CBC (COMPLETE BLOOD COUNT) SOLENOIDS, PELTIER ASSEMBLY, AND PUMP MODULE. THE FSE DISCOVERED A DISCONNECTED TUBING FROM VACUUM CHAMBER VC2 TO SWEEPFLOW ASSEMBLY. THE FSE REPLACED ALL PILOT ACTUATORS ON THE PUMP MODULE, THE RESTRICTOR TUBING AND THE CHECK VALVE TO VC2. THE FSE NOTED THAT THE COMPONENTS THAT HAD DRIED LEAK WOULD BE REPLACED AT A LATER DATE AS A PRECAUTION. THE FSE ALSO OBSERVED THAT THE FRONT AND REAR BLOOD DETECTORS WERE ABOVE THE ACCEPTABLE UPPER VOLTAGE LIMIT. THE FSE REMOVED AND CLEANED THE BSV (BLOOD SAMPLING VALVE) ASSEMBLY AND ALIGNMENT BAR, AND ADJUSTED THE BLOOD DETECTORS TO ESTABLISHED VOLTAGE VALUES. THE FSE ALSO REPORTED THAT THE % CV (COEFFICIENT OF VARIATION) VALUES FOR DIFFERENTIAL AND RETIC SCATTER WERE ON THE BORDERLINE OF THE ESTABLISHED VALUE. THE FSE RESOLVED THE ISSUE BY CLEANING THE FLOWCELL AND ADJUSTING THE TTM (TRIPLE TRANSDUCER MODULE) ALIGNMENT. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A DISCONNECTED TUBING FROM VC2 TO SWEEPFLOW ASSEMBLY, TO THE FRONT AND REAR BLOOD DETECTORS, AND TO THE FLOW CELL MODULE. THERE WAS NO INJURY OR EXPOSURE REPORTED BY THE CUSTOMER AS A RESULT OF THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER FAILED STARTUP FOR RBC (RED BLOOD CELL) AND PLATELETS. NO ERRONEOUS RESULTS WERE ASSOCIATED WITH THE EVENT AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251538 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1