BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4191030 · Received October 21, 2014

    Report

    Report Number
    1061932-2014-02623
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND A CLOGGED PORT IN WASTE CHAMBER VC26 CAUSING THE WASTE CHAMBER TO OVERFLOW. THE FSE CLEARED THE CLOG AND THE INSTRUMENT RAN WITHOUT LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED CLEAR FLUID LEAK OF APPROXIMATELY TWENTY (20) ML UNDER THE TRIPLE TRANSDUCER MODULE (TTM) INSIDE THE COULTER LH 780 HEMATOLOGY ANALYZER. THERE WAS NO REPORT 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, GOGGLES, AND LABORATORY COAT WHEN THE LEAK OCCURRED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670124 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1