BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL

    MDR report key: 3042840 · Received April 4, 2013

    Report

    Report Number
    8030665-2013-00181
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    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 PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER DURING TREATMENT. UPON REMOVING THE CASSETTE FOLLOWING TREATMENT, FLUID WAS FOUND INSIDE THE CYCLER. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138389 LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12SR08011

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER