BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3250030 · Received July 26, 2013

    Report

    Report Number
    1061932-2013-01500
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND OBSERVED A LEAK FROM A DISCONNECTED TUBING AT THE FOAM TRAP FMT3. THE FSE REPLACED THE AFFECTED TUBING TO RESOLVE THE LEAK AND COMPLETED THE PM (PREVENTIVE MAINTENANCE). THE FSE STARTED UP THE INSTRUMENT TO VERIFY REPAIRS AND OBSERVED THAT THE WIRES TO THE WBC (WHITE BLOOD CELL) OVERFLOW SENSOR WERE BROKEN. THE FSE REPLACED THE WBC OVERFLOW SENSOR AND NO FURTHER LEAKS WERE OBSERVED. FAILURE MODE OF THE LEAK AND VACUUM ERRORS IS ATTRIBUTED TO A DISCONNECTED RESTRICTOR TUBING AT THE FOAM TRAP FMT3. THE FSE ALSO DISCOVERED THAT THE WBC OVERFLOW SENSOR WERE BROKEN. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING A LEAK COMING FROM THE FOAM TRAP OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER WHILE TROUBLESHOOTING FOR "LOW VACUUM OUT OF RANGE" ERRORS. THE CUSTOMER INDICATED THAT APPROXIMATELY 1 - 2 ML OF FLUID LEAKED BUT WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND EYEGLASSES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED 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
    351081 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1