BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2634675 · Received June 29, 2012

    Report

    Report Number
    2050012-2012-01343
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012 CUSTOMER REPORTED THAT THE CARTRIDGE CHEMISTRY (CC) SAMPLE CRANE, ON THE DXC 600 PRO HAD A CONTINUOUS LEAK. CUSTOMER STATED THAT THE INSTRUMENT ALSO EXPERIENCED FAILED CALIBRATIONS FOR UREA NITROGEN (BUN), CREATININE (CR-S), AND PHOSPHORUS (PHS). CUSTOMER PERFORMED PREVENTIVE MAINTENANCE ON THE SYSTEM PRIOR TO THE EVENT. CUSTOMER STATED THAT THEY FOUND 3 PUDDLES OF FLUID ON THE SAMPLE WHEEL COVER AND DESCRIBED THE EVENT AS A CONTINUOUS LEAK FROM THE CRANE. THE LEAK WAS ISOLATED AND CLEANED BY THE CUSTOMER. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE AND WAS NOTIFIED BY THE CUSTOMER THAT THEY HAD IDENTIFIED LOOSE CC PROBE WASH TUBING AS THE CAUSE OF THE LEAK. CUSTOMER SECURED THE TUBING PRIOR TO THE ARRIVAL OF THE FSE. THIS RESOLVED THE ISSUE. THE SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES.

    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. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1