BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3160773 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01050
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A SMALL UNCONTAINED LEAK AT ONE OF THE FITTINGS ON THE HIGH PRESSURE DRYER MEMBRANE ON THE AIR CYLINDER (CL11). THE FSE REPLACED THE DRYER MEMBRANE FITTING AT CL11 TO RESOLVE THE LEAK. THE FSE ALSO REPLACED THE RED STRIPE TUBING AT PINCH VALVE PV11 AND PV12 ALONG WITH ALL TUBING AT PV49 AS PART OF A PREVENTATIVE MAINTENANCE. THE FSE ADJUSTED THE DISTANCE THAT THE PROBE WASH BLOCK WILL TRAVEL DOWN THE PROBE DURING WASH TO CORRECT THE DILUENT ERRORS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO DRYER MEMBRANE FITTING AT CL11 AND FAILURE MODE OF THE DILUENT ERROR IS ATTRIBUTED TO A MISALIGNED PROBE WASH RINSE BLOCK. RESULTS: DRYER MEMBRANE FITTING AT CL11 AND MISALIGNED PROBE WASH RINSE BLOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF APPROXIMATELY 5 ML FROM THE BACKWASH CUP INVOLVING THE LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT BUT THE CUSTOMER WAS WEARING GLOVES, GOGGLES, AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. 'DILUENT OUT' ERRORS WERE ALSO GENERATED AT THE TIME OF THE EVENT. 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
    260606 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1