BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3233170 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01499
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A LEAK DUE TO A LOOSE TUBING THROUGH PINCH VALVE PV49 AT THE FEED THROUGH FITTING FF183. PINCH VALVE PV49 PROVIDES OPEN PATH FOR VACUUM AND DILUENT TO THE BACKWASH PUMP PM8. PINCH VALVE PV49 ALSO PROVIDES AN OPEN VACUUM PATH FROM PROBE WIPE TO THE DIFFERENTIAL WASTE CHAMBER VC7. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE TUBING THROUGH PINCH VALVE PV49 WHICH WAS LOOSE AT THE FITTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK INSIDE THE LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT APPROXIMATELY 0.5 ML OF FLUID LEAKED AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE WEAR, AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS 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
    334375 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1