BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3160756 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01052
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED BUT INDICATED THAT THE CUSTOMER HAD RESOLVED THE LEAK PRIOR TO THE FSE'S ARRIVAL. THE CUSTOMER DISCOVERED A LEAK FROM A TORN TUBING AT THE BOTTOM OF THE SHEATH TANK AND PROCEEDED TO REPLACE THE TORN TUBING TO RESOLVE THE LEAK. THE CUSTOMER INDICATED THAT QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATIONS FOLLOWING THE REPAIR. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A TORN TUBING AT THE BOTTOM OF THE SHEATH TANK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NORMAL QC (QUALITY CONTROL) DIFFERENTIAL COUNTS WERE OUT OF SPECIFICATION FOLLOWING PREVENTATIVE MAINTENANCE WHICH WAS PERFORMED ON LH 500 HEMATOLOGY ANALYZER ON THE PREVIOUS DAY. A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) SUGGESTED THE CUSTOMER TO BLEACH THE ASPIRATION PATHWAY AND THE CUSTOMER CALLED BACK TO REPORT A CLEAR FLUID LEAK OF APPROXIMATELY 1/2 CUP FROM THE BSV (BLOOD SAMPLING VALVE). THE CUSTOMER INDICATED THAT THE FLUID WAS NOT CONTAINED WITHIN THE INSTRUMENT BUT THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE ASSOCIATED WITH THIS EVENT 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
    260850 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1