BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2392826 · Received December 30, 2011

    Report

    Report Number
    2050012-2011-08586
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT WHILE PREPARING TO PERFORM THE WEEKLY MAINTENANCE PROCEDURE ON THE UNICEL DXC 600 SYNCHRON SYSTEM, CUSTOMER NOTICED FLUID UNDERNEATH THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE, WHICH WAS LEAKING. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED CUSTOMER WITH TROUBLESHOOTING THE INSTRUMENT BY INSTRUCTING CUSTOMER TO CHECK ALL FITTINGS AND TO REPLACE THE CC SAMPLE PROBE. AFTER PRIMING THE INSTRUMENT 20 TIMES, NO FURTHER LEAKING WAS OBSERVED. HOWEVER, CUSTOMER ONCE AGAIN NOTICED LEAKING FROM THE CC SAMPLE PROBE DURING PROBE ALIGNMENT. THE CTS THEN GENERATED A SERVICE REQUEST. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT A TUBE ON THE T-VALVE WAS LOOSE. THE FSE REPLACED THE T-VALVE AND PERFORMED INSTRUMENT ALIGNMENTS. FINALLY, THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER INSTRUMENT ISSUES. CUSTOMER STATED THAT NO ONE WAS HARMED BY OR EXPOSED TO THE INSTRUMENT LEAK, AND THAT PATIENT SAMPLES AND RESULTS WERE NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1