BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4201362 · Received October 27, 2014

    Report

    Report Number
    1061932-2014-02663
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 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, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) DISCOVERED THE LEAK WAS DUE TO CUT ERYTHROLYSE REAGENT PUMP (PM6) TUBING AT THE INLET PORT OF THE BLOOD SAMPLING VALVE (BSV) CENTER PAD. THE FSE TRIMMED AND REATTACHED THE TUBING TO RESOLVE THE LEAK AND DIFFERENTIAL VOTE OUTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING DIFFERENTIAL VOTE OUTS WHILE RUNNING CONTROLS ON THE COULTER LH 500 HEMATOLOGY ANALYZER. THE REPORTED ISSUE WAS ASSOCIATED WITH A CONTAINED TWO (2) DROPS OF FLUID LEAK FOUND DURING STARTUP. THERE WAS NO REPORT OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE FLUID, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND LABORATORY COAT WHEN THE LEAK WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684584 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1