BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3915437 · Received June 5, 2014

    Report

    Report Number
    8030665-2014-00463
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    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 PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    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. PATIENT NOT ABLE TO FINISH TREATMENT LAST NIGHT DUE TO A FLUID LEAK. PATIENT FOUND A LEAK INSIDE THE CASSETTE DOOR. PATIENT HAD NO ADVERSE EFFECTS AND HIS EFFLUENT REMAINED CLEAR. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328835 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER