BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3181145 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01214
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A LOOSE LOWER SHEATH TUBING TO THE FLOW CELL. THE FSE REPLACED THE LOWER SHEATH TUBING TO THE FLOW CELL TO RESOLVE THE LEAK, THE DIFFERENTIAL VOTE OUT, AND "SHEATH TANK NOT FULL" ERROR. FAILURE MODE IS ATTRIBUTED TO A LOOSE LOWER SHEATH TUBING TO THE FLOW CELL AND THE INSTRUMENT GENERATED DIFFERENTIAL VOTE OUT AND "SHEATH TANK NOT FULL" ERROR TO ALERT THE OPERATOR OF AN INSTRUMENT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLENZ LEAK INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER WHICH OCCURRED WHILE RUNNING SAMPLES. THE VOLUME OF THE LEAK IS UNKNOWN BUT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND CLENZ LEAKED ONTO THE COUNTER. THE INSTRUMENT GENERATED DIFFERENTIAL VOTE OUT AND "SHEATH TANK NOT FULL" ERRORS. 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 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
    283257 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1