BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2393640 · Received January 2, 2012

    Report

    Report Number
    2050012-2011-08502
    Event Type
    Malfunction
    Date Received
    January 2, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: WASH BOTTLE ASSEMBLY. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK FROM WASH BOTTLE 2 OF THE SYNCHRON CX 5 DELTA CLINICAL SYSTEM. CUSTOMER REPORTED THAT THERE WAS FLUID ON THE BOTTLE CAP. CUSTOMER REPORTED THAT THERE WAS A SMALL PUDDLE UNDER THE INSTRUMENT. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH BOTTLE ASSEMBLY. THE REPLACEMENT OF THE WASH BOTTLE ASSEMBLY RESOLVED THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1