BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 3032880 · Received March 29, 2013

    Report

    Report Number
    8030665-2013-00173
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    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 DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    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, THE CASSETTE APPEARED TO HAVE LEAKED SOLUTION INTO THE CYCLER. THE ORIGIN OF THE LEAK IS THOUGHT TO BE WHERE THE TUBING CONNECTS TO THE CASSETTE, BUT CANNOT BE CONFIRMED. THERE IS NOT REPORT OF PT ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130102 LIBERTY CYCLER SET, SINGLE CONN/EXT DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12HR08809

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER