BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2060422 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01170
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE FOUND VALVE L5 TO BE FAULTY, NOT OPENING TO PRESSURE, LIQUID TRAP WAS CONSTANTLY UNDER VACUUM RESERVOIR. REPLACED L5 WITH L6, AND THIS CORRECTED THE PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FLUID LEAK FROM VACUUM EXHAUST FILTER ON BACK OF SYNCHRON CX5 DELTA CLINICAL SYSTEM. NO REPORT OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1