BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4112400 · Received September 24, 2014

    Report

    Report Number
    1061932-2014-02377
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAK WAS CAUSED BY BUILDUP ON BLOOD SAMPLING VALVE (BSV) ALIGNMENT BAR. THE CUSTOMER WAS ABLE TO CLEAN THE BSV ALIGNMENT BAR AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED LEAK FROM THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK CONSISTED OF DILUENT, BLOOD AND CLENZ REAGENT. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT WHEN THE LEAK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593208 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1