BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER

    MDR report key: 2089179 · Received May 16, 2011

    Report

    Report Number
    1061932-2011-00413
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE CRACKED FEED-THRU FITTING FOR WASTE AND DILUENT. FSE CLEANED AND DISINFECTED THE AREA WHERE THE LEAK OCCURRED. THE FSE VERIFIED THE REPAIR AND VALIDATED THE SYSTEM. ROOT CAUSE WAS A CRACKED WASTE FITTING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SMALL LEAK / DRIP FROM A WASTE FITTING BEHIND THE RIGHT SIDE DOOR THAT EXITS OUT THE BACK OF THE COULTER AC T 5DIFF CP. ON (B)(6) 2010, THE CUSTOMER SUBMITTED TWO PATIENT'S RESULTS. NO EXPOSURE TO MUCUS MEMBRANES OR OPEN WOUNDS AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION FOR THIS EVENT. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER, GKZ BECKMAN COULTER INC. ACT 5DIFF CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1