BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER

    MDR report key: 2769102 · Received October 2, 2012

    Report

    Report Number
    1061932-2012-02479
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT APPROXIMATELY 20ML OF DILUENT LEAKED FROM THE COULTER HMX HEMATOLOGY ANALYZER ONTO THE COUNTER. THE LEAK APPEARED TO BE BY PINCH VALVE PV49 AND WAS NOTICED AFTER THE INSTRUMENT WAS IN SHUTDOWN. THE CUSTOMER WAS WEARING GLOVES, A LAB COAT, AND GOGGLES AT THE TIME OF THE OCCURRENCE. THERE WAS NO INJURY OR EXPOSURE TO THE LEAK. MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE TUBING THROUGH PINCH VALVE PV49 WAS LEAKING. THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1