BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4111761 · Received September 23, 2014

    Report

    Report Number
    1061932-2014-02407
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND A CLOT IN THE VACUUM PATH AT THE LOWER PART OF THE RINSE BLOCK, WHICH CAUSED A LEAK AT THE END OF EVERY SECONDARY ASPIRATION CYCLE. THE FSE CLEANED THE CLOT TO RESOLVE THE LEAK. AS PREVENTATIVE MEASURES, THE FSE ADJUSTED THE RINSE BLOCK POSITION AND PROBE ANGLE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM A COULTER LH 500 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS APPROXIMATELY TWO OR THREE DROPS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE LEAK. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592274 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1