BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS WASH BUFFER II SOLUTION

    MDR report key: 2465951 · Received February 23, 2012

    Report

    Report Number
    2122870-2012-00472
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 5, 2012
    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. REVIEW OF CUSTOMER PROVIDED PHOTOS INDICATED A CUBETAINER WITH SOME FLUID LOSS AND CORRUGATED BOX DAMAGE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE CUSTOMER REPORTED THE RECEIPT OF A CUBETAINER OF ACCESS WASH BUFFER II SOLUTION WHOSE INTERNAL BLADDER SIDE SEAM WAS DAMAGED, CAUSING THE WASH BUFFER TO LEAK. THE LEAK WAS DISCOVERED IN THE CUSTOMER'S WAREHOUSE AREA. 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 AMOUNT OF LEAKAGE FOR THIS EVENT COULD NOT BE DETERMINED. THERE WAS NO INDICATION THAT THE FLUID HAD REACHED THE FLOOR. 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 POSSESSED 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 331880F

    Patients

    Seq Age Sex Outcome Treatment
    1