BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2120921 · Received June 13, 2011

    Report

    Report Number
    1061932-2011-00631
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K922704
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A FIELD SERVICE ENGINEER (FSE) WAS ABLE TO DRAIN THE BELLOWS AND FLUSH VACUUM TRAP BY REPLACING THE ACTUATORS FOR PINCH VALVES (PV) 20, 21, AND 22. PINCH VALVES ROUTE PRESSURE, VACUUM AND REAGENTS. THE ROOT CAUSE OF THIS EVENT WAS ATTRIBUTED TO THE NEEDLE BELLOWS NOT DRAINING DUE TO THE ACTUATORS STICKING FOR PINCH VALVES (PV) 20, 21, AND 22.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT BELLOWS WERE NOT DRAINING AND THAT A SMALL LEAK OF ISOTON AND BLOOD WAS OBSERVED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND EYE PROTECTION NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HEMATOLOGY ANALYZER, GKZ BECKMAN COULTER INC. HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1