BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3 DELTA

    MDR report key: 2213580 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04569
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJF
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, FIELD SERVICE ENGINEER (FSE) VISITED AND FOUND AN EVIDENCE OF SOME FORM OF OVERFLOWING; HOWEVER THE ISSUE IS NO LONGER OCCURRING. PER FSE, CX3 OVERFLOW PAN SHOWED EVIDENCE OF CREATININE AND WASH FLUID RESIDUE. FSE CLEANED, SECURED ALL WASTE LINES, TUBING, AND CHECKED TRAP, CUPS PUMPS, AND REAGENTS FOR LEAKS. NO FURTHER LEAKING OBSERVED. PRIMED THE UNIT X80 WITH NO LEAKS NOTED. UNABLE TO REPRODUCE ISSUE DESPITE RUNNING FOR CLOSE TO 100 CYCLES. A DEFINITIVE ROOT CAUSE IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT FLUID LEAK UNDERNEATH THE SYNCHRON CX3 DELTA. THE CUSTOMER USED PERSONAL PROTECTIVE EQUIPMENT TO CLEAN THE LEAK. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3 DELTA MICRO CHEMISTRY ANALYZER FOR CLINICAL USE JJF BECKMAN COULTER INC. CX3 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1