BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 2943129 · Received January 21, 2013

    Report

    Report Number
    8030665-2013-00049
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT WAS IN FILL ONE OF TREATMENT. THE LEAK WAS OBSERVED TO HAVE COME FROM THE DOMES OF THE CASSETTE. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28846 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 11PR08013

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER