BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX DELTA CLINICAL SYSTEM, MODEL CX5

    MDR report key: 2342585 · Received November 18, 2011

    Report

    Report Number
    2050012-2011-07496
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 20, 2011
    Report Date
    October 20, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 THE OBSTRUCTION DETECTOR (ODC) WAS LEAKING INTO THE TRAY IN THE BACK OF THE SYNCHRON CX DELTA CLINICAL SYSTEM. THE CUSTOMER TECHNICAL SPECIALIST GENERATED A SERVICE REQUEST. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE ODC TRANSDUCER MEMBRANE WAS RUPTURED, CAUSING FLUID TO FLOW OUT OF THE DRAIN LINE. THE FSE THEN REPLACED THE ODC TRANSDUCER, WHICH RESOLVED THE INSTRUMENT ISSUE. THE FSE THEN VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE ISSUE. CUSTOMER STATED THAT PATIENT RESULTS AND SAMPLES WERE NOT AFFECTED, AND THAT NO ONE WAS HARMED BY OR EXPOSED TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX DELTA CLINICAL SYSTEM, MODEL CX5 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX5

    Patients

    Seq Age Sex Outcome Treatment
    1