BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2242261 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01415
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. INVESTIGATION OF THIS ISSUE IS ON-GOING. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 1061932-2011-01415, 1061932-2011-01414.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. OPERATOR REPORTED OBSERVING A BLOODY LEAK AROUND THE NUCLEATED RED BLOOD CELL (NRBC) CHAMBER OF TWO UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS AT A BECKMAN COULTER INC. FACILITY. THIS IS REPORT TWO OF TWO AND REPRESENTS THE BLOODY LEAK FOUND ON ONE OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS WITH SERIAL NUMBER (B)(4). THE OPERATOR NOTICED THE LEAK AT THE OPEN STAINLESS STEEL PORT OF THE NRBC CHAMBER WHEN PROCESSING QUALITY CONTROL SAMPLES. THE LEAK WAS CLEANED PER LABORATORY PROTOCOL. THE OPERATOR INTERFACING WITH THE MACHINE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT, WHICH INCLUDED A LABORATORY COAT, EYE PROTECTION AND GLOVES, AT THE TIME OF OCCURRENCE THERE WAS NO BIOHAZARDOUS EXPOSURE TO OPERATOR UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURY WAS REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1