BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4101877 · Received September 19, 2014

    Report

    Report Number
    1061932-2014-02328
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE OBSERVED ISOTON OR CLEANER LEAKING FROM DISCONNECTED TUBING AT QUICK DISCONNECT QD5. THE TUBING WAS RECONNECTED TO RESOLVE THE LEAK. THE INSTRUMENT WAS VERIFIED TO MEET SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 2 ML OF DILUENT AND CLEANER LEAKED FROM A COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER WHILE THE INSTRUMENT WAS PROCESSING SAMPLES. THE LEAK OCCURRED ON THE RIGHT SIDE OF THE INSTRUMENT AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES, A LAB COAT, AND EYEGLASSES AT THE TIME OF THE LEAK. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582318 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1