BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2485678 · Received March 9, 2012

    Report

    Report Number
    1061932-2012-00828
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE PROBE LEAK IS VL341 WAS NOT OPENING/CLOSING. THE SOLENOID FAILED BECAUSE IT HAD LEAKED INTERNALLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. TO REPORT ASPIRATION ERRORS AND BLOOD DRAINING OUT OF THE PROBE ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE AMOUNT OF FLUID LEAK FROM THE ASPIRATION PROBE WAS ABOUT 2 ML AND WAS CONTAINED WITHIN THE INSTRUMENT. THE ASPIRATION PROBE AND PROBE WASH ASSEMBLY COULD CONTAIN BLOOD, CONTROLS, AND DXH DILUENT DURING NORMAL OPERATION OR DXH CLEANER DURING SHUTDOWN. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LAB COAT, AND PROTECTIVE EYE-WEAR AT THE TIME OF THE INCIDENT. PATIENT SAMPLES OR RESULTS WERE NOT REPORTED TO HAVE BEEN AFFECTED BY THE LEAK. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REPORT EXPOSURE (SPLASHED OR SPRAYED) TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER PERFORMED A BLEACHING PROCEDURE BUT THE PROBE CONTINUED TO DRIP. THE CUSTOMER REQUESTED SERVICE FOR THE UNIT. ON THE DAY OF THE EVENT ((B)(6) 2012) THE FSE FOUND THE PROBE WIPE LEAKING AND REPLACED VL341. VL341 IS A SOLENOID ON MANIFOLD (MF340) FOR PROBE WASTE DISTRIBUTION. THE FSE REPLACED THE PROBE WIPE, CONNECTED PROBE VL303 AND REPLACED THE COMPRESSOR. THE FSE CONFIRMED ON (B)(4) 2012 VL341 WAS THE CAUSE OF THE PROBE WIPE LEAKING. THE SOLENOID WAS NOT OPENING OR CLOSING AT ALL; IT HAD LEAKED INTERNALLY. THE PROBE LEAK WAS CONTAINED INSIDE THE INSTRUMENT. ALL OF THE OTHER REPAIRS MADE DURING THE SERVICE CALL WERE DUE TO PROBLEMS THE FSE OBSERVED WHILE PERFORMING HIS VERIFICATION.

    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. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1