BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3223225 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01349
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND OBSERVED DRIPS FROM THE MOLDED END OF THE LOWER SHEATH RESTRICTOR TUBING. THE FSE REPLACED THE LOWER SHEATH RESTRICTOR LINE AT PINCH VALVE VL169 TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE LOWER SHEATH RESTRICTOR TUBING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING A CLEAR FLUID LEAK OF APPROXIMATELY 10 ML BELOW THE COULTER LH 750 HEMATOLOGY ANALYZER AFTER PERFORMING AN F44 AND F45 (FLOW CELL PURGE) TO TROUBLESHOOT AN INSTRUMENT-GENERATED "FLOW CELL CLOG" MESSAGE. THE CUSTOMER INDICATED THAT FLUID LEAKED ONTO THE COUNTERTOP. THE OPERATOR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324549 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1