BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL SYSTEMS

    MDR report key: 2120814 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02091
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011 A BCI FIELD SERVICE ENGINEER (FSE) REPLACED WASTE EXIT SUMP FLOAT SWITCH. NO FURTHER ISSUES HAVE BEEN REPORTED SINCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A FLOOD WASTE COLLECTION ON THE LEFT SIDE OF INSTRUMENT IS LEAK. THE LEAK IS FROM THE WASTE SUMP B. THE CUSTOMER REPLACED A FEW INLINE FILTER AND CHANGED A LINE USING PERSONAL PROTECTIVE EQUIPMENT (PPE). CUSTOMER DISCOVERED THAT THE CANISTER IS STILL LEAKING AND THE O-RING LOOKS WORN. NO INJURY OR PERSONNEL EXPOSURE WAS REPORTED CHEMICALS OR BIOHAZARDS UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX 20 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1