BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2110103 · Received June 1, 2011

    Report

    Report Number
    1061932-2011-00520
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED AND THE FIELD SERVICE ENGINEER (FSE) REPLACED THE BROKEN VACUUM TRAP AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURE. THE ROOT CAUSE IS ATTRIBUTED TO THE BROKEN VACUUM TRAP CAUSING RAW VACUUM TO BE LOW. IT MADE THE NEEDLE UNABLE TO DRAIN, RESULTING IN NEEDLE OVERFLOW, HENCE CAUSING THE LEAK.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) AND REPORTED A BLOOD LEAK FROM THE NEEDLE CARTRIDGE OF COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WAS NO EXPOSURE OR CONTACT WITH THE EYES, SKIN, MUCOUS MEMBRANES, OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE FACILITY HAS AN EXPOSURE CONTROL PLAN OR RISK MANAGEMENT PLAN IN PLACE. MSDS SHEETS WERE NOT REVIEWED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1