BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3951267 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01687
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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 ASPIRATION ISSUES DUE TO A CLOT IN THE PROBE WASH VACUUM, WHICH RESTRICTED THE VACUUMING OF BACKWASH TO WASTE. THE FSE CLEANED THE BLOOD SAMPLING VALVE (BSV) AND VACUUM TUBING TO RESOLVE THE LEAK. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE PROBE OF A COULTER LH 500 HEMATOLOGY ANALYZER, WHICH WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES AT THE TIME OF THE LEAK; THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED AND NO IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428303 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1