BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2746098 · Received September 14, 2012

    Report

    Report Number
    1061932-2012-02436
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT FLUID WAS LEAKING FROM THE BLOOD SAMPLING VALVE MANUAL PROBE OF THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER) ONTO THE COUNTER. CUSTOMER REPORTED THE LEAK OCCURRED WHILE THE HMX AUTOLOADER WAS PERFORMING LATRON CONTROL RUN. CUSTOMER REPORTED THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. CUSTOMER REPORTED THE FLUID APPEARED TO BE DILUENT. CUSTOMER REPORTED THE VOLUME OF THE LEAK WAS APPROXIMATELY 10 - 15 CUBIC CENTIMETERS. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE PROBE BLOCK AIR CYLINDER CRACKED, NOT ALLOWING THE PROBE BLOCK TO FULLY EXTEND DOWN THE MANUAL PROBE AND A SINGLE DROP OF FLUID WOULD DRIP ONTO THE FRONT PANEL. THE FSE REPLACED THE AIR CYLINDER TO RESOLVE THE DRIP ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1