BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2913423 · Received January 9, 2013

    Report

    Report Number
    8030665-2013-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2012
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS PERFORMING A REVIEW OF THE PT MEDICAL RECORD INFO. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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. UPON REMOVING THE TUBING SET FOLLOWING TREATMENT, MOISTURE WAS NOTICED INSIDE THE CYCLER. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13306 LIBERTY CYCLER SET, DUAL PATIENT CONNECT LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12HR08094

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LIBERTY DIALYSIS CYCLER