BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH780 HEMATOLOGY ANALYZER

    MDR report key: 2930503 · Received January 28, 2013

    Report

    Report Number
    1061932-2013-00046
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER LH 780 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 1ML OF BLOODY FLUID FROM THE MANUAL PROBE TO THE TABLE TOP. THE CUSTOMER WAS WEARING GLOVES, A LAB COAT, AND EYE PROTECTION AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE. THE INSTRUMENT GENERATED ERRONEOUS RESULTS FOR ONE PATIENT WITHOUT FLAGS. THE RESULTS WERE HIGH ON RED BLOOD CELL, HEMATOCRIT, AND PLATELET AND LOW ON MCH AND MCHC WHEN COMPARED TO THE RESULTS FROM AN ALTERNATE INSTRUMENT. THE RESULTS FROM THE ALTERNATE INSTRUMENT WERE CONSIDERED CORRECT, AND THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE FIELD SERVICE ENGINEER (FSE) OBSERVED A LEAK UNDER THE BSV (BLOOD SAMPLING VALVE) AND FOUND THAT THE PROBE WAS LEAKING DILUENT. THE FSE NOTED THAT THE BSV LEVER SHAFT AND CAP WERE NOT SEATED CORRECTLY AND BSV LEVER SHAFT WAS RUBBING AGAINST SCREW IN MOUNT CAUSING THE BSV TO SHIFT ERRATICALLY AND SEPARATING THE BSV SECTIONS. THE FSE READJUSTED THE BSV LEVER SHAFT AND CAP ON CORRECTLY, CLEANED THE BSV, AND FLUSHED OUT QD26 POSITION 5 WITH BLEACH. THE FSE ALSO CHECKED DRAINAGE FROM RINSE CUP FOR BLOCKAGE AS PREVENTIVE MEASURE. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37497 COULTER® LH780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1