BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3233421 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01401
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    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 TO THE CUSTOMER'S SITE. THE FSE CONFIRMED A CLENZ LEAK COMING FROM A TORN GREEN STRIPE TUBING THROUGH THE RINSE BLOCK. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A TORN TUBING THROUGH THE RINSE BLOCK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING A CLENZ LEAK WHICH WAS CONTAINED IN THE BSV (BLOOD SAMPLING VALVE) DRIP TRAY AFTER COMPLETING A SHUTDOWN ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK CONSISTING OF APPROXIMATELY 10 ML OF CLEANER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT 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. THE CUSTOMER STATED THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334277 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1