BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT DL

    MDR report key: 3061436 · Received April 10, 2013

    Report

    Report Number
    8030665-2013-00199
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG 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 PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT WAS IN DWELL FOUR OF SIX. UPON REMOVING THE TUBING SET FROM THE CYCLER, FLUID WAS NOTICED INSIDE THE CYCLER. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. PATIENT HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED BY THE PATIENT; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149855 LIBERTY CYCLER SET, SINGLE CONN./EXT DL LIBERTY DIALYSIS CYCLER TUBING FKX ERIKA DE REYNOSA, S.A. DE C.V. 13AR08800

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER