BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4183902 · Received October 20, 2014

    Report

    Report Number
    1061932-2014-02620
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND A WHOLE IN THE TUBING THROUGH PINCH VALVE VL27. THE FSE REPLACED THE TUBING THROUGH PINCH VALVE VL27 AND THE INSTRUMENT RAN WITHOUT ANY LEAKS OR ERRORS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED FLUID LEAK OF APPROXIMATELY ONE (1) ML UNDER THE PUMP MODULE OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE INSTRUMENT WAS GENERATING DIFFERENTIAL VOTE OUTS AND "FLOW CELL CLOG" ERROR MESSAGES WHEN THE LEAK WAS OBSERVED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES, AND LABORATORY COAT WHEN THE LEAK OCCURRED. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. 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
    664629 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1