BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2103114 · Received May 25, 2011

    Report

    Report Number
    2050012-2011-01590
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND TUBING JOINING MODULAR CHEMISTRY (MC) SIDE IN THE HYDRO COMPARTMENT DETERIORATED AND CRACKED. FSE FOUND SUITABLE REPLACEMENT LOCAL HARDWARE. FSE REPLACED TUBING AND VERIFIED NO LEAKAGE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK IN THE SYNCHRON CX5 DELTA CLINICAL SYSTEM. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1