BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGEL CONN./EXT.DL

    MDR report key: 3202141 · Received June 28, 2013

    Report

    Report Number
    8030665-2013-00404
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 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 MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCE'S 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. PT DISCOVERED FLUID INSIDE THE CASSETTE DOOR AND HEAD PUMP AREA WHEN REMOVING THE TUBING SET. LEAK LOCATION COULD NOT BE IDENTIFIED. PT HAD NO ADVERSE EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296606 LIBERTY CYCLER SET, SINGEL CONN./EXT.DL FKX REYNOSA MANUFACTURING 13CR08903

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER