BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3230615 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01398
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED THAT THE LEAK WAS NOT COMING FROM THE BSV, BUT WAS INSTEAD COMING FROM THE BLACK RINSE BLOCK ON THE PROBE WIPE ASSEMBLY. THE FSE REMOVED AND INSTALLED A NEW PROBE WIPE ASSEMBLY WHICH DID NOT WORK PROPERLY. THE FSE THEN CLEANED, REPAIRED, AND REINSTALLED THE OLD PROBE RINSE BLOCK ON THE PROBE WIPE ASSEMBLY. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. RESULTS: FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE BLACK RINSE BLOCK ON THE PROBE WIPE ASSEMBLY. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BSV (BLOOD SAMPLING VALVE) OF THE COULTER LH 780 HEMATOLOGY ANALYZER WAS LEAKING FLUID INTO THE DRIP TRAY. THE CUSTOMER STATED THAT GREEN COLORED FLUID WAS NOTICED IN THE DRIP TRAY WHILE PERFORMING WEEKLY MAINTENANCE ON THE INSTRUMENT. THE VOLUME OF THE LEAK IS UNKNOWN BUT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, FACE SHIELD, AND GLOVES 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
    328071 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1