BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 2932414 · Received January 22, 2013

    Report

    Report Number
    8030665-2013-00046
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT WAS IN THE LAST DRAIN OF TREATMENT. UPON OPENING THE CASSETTE DOOR, FLUID WAS LEAKING. PT HAD NO ILL EFFECTS. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31480 LIBERTY CYCLER SET, SINGLE CONN./EXT.DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12LR08069

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER