BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS WASH BUFFER II SOLUTION

    MDR report key: 2309064 · Received October 26, 2011

    Report

    Report Number
    2122870-2011-04645
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 28, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF THE CUSTOMER SUPPLIED PHOTOS ELIMINATED NECK DETACHMENT, PIN HOLES NEAR THE TOP SHOULDER, AND WEEPING AS POSSIBLE CAUSES, HOWEVER, COULD NOT DEFINITIVELY IDENTIFY THE CAUSE OF THE LEAK. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CUSTOMER OBSERVED ONE LEAKING CUBETAINER OF ACCESS WASH BUFFER II SOLUTION. IT IS UNKNOWN AS TO WHETHER PERSONNEL HANDLING THE CUBETAINER WERE WEARING PERSONAL PROTECTIVE EQUIPMENT; HOWEVER, THERE WAS NO REPORT OF ANY PERSONNEL SEEKING MEDICAL ATTENTION ASSOCIATED WITH THIS EVENT. THE ISSUE WAS DETECTED IN A DEALER'S WAREHOUSE. THE AMOUNT OF LEAKAGE FOR THIS EVENT COULD NOT BE DETERMINED. ALTHOUGH THE FLUID VOLUME OF AN ACCESS WASH BUFFER II CUBETAINER IS THEORETICALLY SIGNIFICANT ENOUGH TO CAUSE A SLIPPING HAZARD IF IT IS SPILLED, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FACILITY POSSESSES A HAZARDOUS EXPOSURE PLAN AND THE MATERIAL SAFETY DATA SHEET WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS WASH BUFFER II SOLUTION REAGENT, GENERAL PURPOSE LDT BECKMAN COULTER, INC. NA 331874F

    Patients

    Seq Age Sex Outcome Treatment
    1