BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2260087 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04626
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    February 17, 2010
    Report Date
    February 18, 2010
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. NO CULTURES OF THE SYSTEM WERE TAKEN OR PROVIDED. THE FSE DECONTAMINATED THE ION-SELECTIVE ELECTRODE SYSTEM, REPLACED ALL ELECTRODES, REPLACED THE ELECTROLYTE INJECTOR CUP, REBUILT THE RATIO PUMP, CLEANED THE FLOW CELL, REPLACED THE MODULAR CHEMISTRY T-VALVE AND SYRINGE AND PERFORMED ALIGNMENTS. ALTHOUGH SEVERAL PARTS WERE REPLACED AND THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY NO CONCLUSION CAN BE DRAWN. THIS IS ONE OF EIGHT INDIVIDUAL MEDWATCH REPORTS AS THE CUSTOMER REPORTED EIGHT SEPARATE PT EVENTS. SEE THE BELOW MDR NUMBERS FOR ALL ASSOCIATED EVENTS: 2050012-2010-00106, 04623, 04624, 04625, 04627, 04628, 04629. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT EIGHT (8) ERRONEOUSLY LOW SODIUM (NA) AND CHLORIDE (CI) RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM FOLLOWING ROUTINE CALIBRATION OF THE SYSTEM. QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO THE EVENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED ON ANOTHER SYSTEM IN THE LABORATORY AND YIELDED RESULTS WITHIN EXPECTATIONS. THE RESULTS WERE AMENDED AND REISSUED. IT IS NOT KNOWN IF THERE WERE ANY CHANGES TO THE PTS' CARE OR TREATMENT. THERE IS NO REPORT OF ANY ADVERSE EVENT OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE A SERIOUS INJURY.

    Devices

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

    Patients

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