BEUDAMED
    FDA Adverse Event Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3121624 · Received May 16, 2013

    Report

    Report Number
    8030665-2013-00294
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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 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 PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT WAS IN DRAIN ONE OF TREATMENT. UPON REMOVING THE TUBING SET, FLUID WAS NOTICED IN THE CYCLER. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. PT WAS NOT ADMINISTERED ANTIBIOTICS AND HAS HAD NO ADVERSE EFFECTS. SAMPLE WAS DISCARDED BY THE PT; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217974 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 12SR08017

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER