BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2210885 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04486
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. CTS ASKED CUSTOMER TO CHECK THE DI (DEIONISED) WATER LINE FROM THE SOURCE TO INSTRUMENT, CUSTOMER DID NOT NOTE ANY LEAK FROM THAT AREA. CTS ASKED TO CHECK IF THE INSTRUMENT ROLLED OVER THE DI WATER LINE. THE CUSTOMER CHECKED AND CONFIRMED THAT THIS HAD NOT OCCURRED. CTS THEN ASKED CUSTOMER TO CHECK THE ISE (ION-SELECTIVE ELECTRODE) AREA TO SEE IF THE LEAK IS COMING FROM ANY TUBINGS IN THAT AREA AND PER CUSTOMER, NONE WERE SEEN. CTS GENERATED A SERVICE REQUEST AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011. UPON OPENING THE PUMP BOX, FSE OBSERVED THAT THE VACUUM PUMP CONDENSATION TUBE WAS INCORRECTLY ROUTED. FSE ROUTED THE TUBE CORRECTLY, REPLACED THE PUMP BOX, PRIMED AND CALIBRATED ISES AND RAN QC. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THIS ISSUE HAS BEEN RESOLVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A LEAK OF UNKNOWN FLUID SEEN AT THE BOTTOM OF THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM TOWARDS THE MODULAR CHEMISTRY (MC) SIDE. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1