BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® SYSTEM

    MDR report key: 2143693 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02528
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED THE SITE ON (B)(4) 2011 AND FOUND THAT DI WATER RESERVOIR FLOAT SWITCH WAS NOT RESPONDING CORRECTLY WHEN CANISTER WAS FULL. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SWITCH, AND THE ISSUE WAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A LOW PRESSURE HIGH ERROR AND A LEAK OBSERVED UNDER WASTE CANISTER OF UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER, WEARING PPE, PLACED PAPER TOWELS UNDER THE INSTRUMENT, AND STOPPED USING THE INSTRUMENT. THE CUSTOMER HAS MSDS AND A WASTE ACTION PLAN IN PLACE. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® SYSTEM DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1