BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 2945388 · Received February 1, 2013

    Report

    Report Number
    8030665-2013-00076
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Manufacturer
    REYNOSA MFG
    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 THE DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. WHEN PT REMOVED THE TUBING SET, PT NOTICED FLUID INSIDE THE CYCLER AND DOWN ON THE CART AND WAS UNABLE TO IDENTIFY LEAK LOCATION. PT HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44960 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MFG 12LR08020

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER