BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3160237 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01061
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND FOUND THE INPUT TUBING TO THE FLOW CELL HAD COME OFF. THE FSE CLEANED THE FITTING ON THE BOTTOM OF THE FLOW CELL AND REPLACED THE TUBING, RESOLVING THE ISSUE. FAILURE MODE WAS DISCONNECTED TUBING FROM THE BOTTOM OF THE FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT APPROXIMATELY 6CC OF BLOODY FLUID LEAKED FROM THE UNICEL DXH 800 COULTER ANALYZER AND ON TO THE FLOOR DURING SHUTDOWN CYCLE. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING GLOVES, A LABORATORY COAT, AND GOGGLES. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. PATIENT SAMPLES WERE NOT AFFECTED. THE INSTRUMENT WAS IN SHUTDOWN AND THERE WERE NO CONTROLS OR PATIENT SAMPLES RUN AT THE TIME WHEN THE LEAK WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260550 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1