BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2211602 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-02923
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    April 7, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE SYSTEM CULTURED POSITIVE FOR PSEUDOMONAS SPP. THE FSE DECONTAMINATED THE SYSTEM AND REPLACED SEVERAL ISE (ION-SELECTIVE ELECTRODE) MODULE PARTS. WHILE THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JAN 1, 2008 AND OCT 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM DUE TO CONTAMINATION. CULTURES OF THE SYSTEM WERE POSITIVE FOR PSEUDOMONAS SPP. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO CHANGE TO THE PTS' CARE OR TREATMENT. THERE IS NO REPORT OF ANY ADVERSE EVENT OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE REFERENCE| ISE ELECTROLYTE BUFFER