BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX WASH SOLUTION

    MDR report key: 2001282 · Received February 24, 2011

    Report

    Report Number
    2050012-2011-00459
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK FROM A CRACK ON SYNCHRON LX WASH SOLUTION CARTRIDGE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES, AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX WASH SOLUTION GENERAL PURPOSE WASH SOLUTION JJE BECKMAN COULTER, INC. NA M008417

    Patients

    Seq Age Sex Outcome Treatment
    1