BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2480606 · Received March 6, 2012

    Report

    Report Number
    1061932-2012-00709
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER) WAS GIVING PARTIAL ASPIRATION ERRORS AND A CASSETTE WAS STUCK ON THE ROCKER BED. CUSTOMER REPORTED THAT THE THERE WAS A BLOODY FLUID LEAK UNDER THE HMX AUTOLOADER. 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) REPLACED THE NEEDLE AND TUBING AT PINCH VALVE PV21. THE FSE RAN SAMPLES AND CONTROLS TO VERIFY OPERATION. THE FSE VERIFIED THE REPAIR AND VALIDATED THE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1