BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS WASH BUFFER II SOLUTION

    MDR report key: 2407287 · Received January 10, 2012

    Report

    Report Number
    2122870-2012-00005
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 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

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF THE CUSTOMER SUPPLIED PHOTOS REVEAL FLUID ON FLOOR AND TWO BOXES OF WASH BUFFER II. THE PHOTOS DID 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 OR TWO LEAKING CUBETAINER(S) 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. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. THE EVENT WAS DISCOVERED AT THE DEALER WAREHOUSE. THE AMOUNT OF LEAKAGE FOR THIS EVENT COULD NOT BE DETERMINED. THE FLUID VOLUME OF AN ACCESS WASH BUFFER II CUBETAINER IS THEORETICALLY SIGNIFICANT ENOUGH TO CAUSE A SLIPPING HAZARD IF IT IS SPILLED, OR SKIN SENSITIZATION IF CONTACT OCCURS. HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FACILITY DOES POSSESS 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 331926F

    Patients

    Seq Age Sex Outcome Treatment
    1