BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 7307017 · Received March 1, 2018

    Report

    Report Number
    2937457-2018-00644
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 9, 2018
    Report Date
    March 1, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INITIAL SIMULATED TREATMENT WAS PERFORMED, FAILED WITH A MWD WATCHDOG TIMER ERROR ALARM. THE FAILURE WAS TRACED TO A BAD CONNECTION BETWEEN A BACKPLANE BOARD AND FUNCTIONAL BOARD. AFTER INSERTING THE BACKPLANE FIRMLY INTO FUNCTIONAL BOARD THE SIMULATED TREATMENT WAS PERFORMED, COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE. THE SYSTEM AIR LEAK PASSED. THE VOLTAGE CHECK PASSED. THE LOAD CELL VALUE AND VERIFICATION WAS WITHIN TOLERANCE. AFTER COMPLETING THE SIMULATION TREATMENT AND OTHER TESTS THERE WERE MWD FAILURES AFTER POWER OFF AND ON, THE FAILURE WAS TRACED TO BAD INTERMITTENT POWER SUPPLY. THE BAD POWER SUPPLY WILL BE REPLACED IN THE PRODUCTION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO OTHER SIGNS OF PHYSICAL DAMAGE. THERE ARE NO VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THERE WAS NO PRESENCE OF VISIBLE LIQUID OR EVIDENCE OF PAST FLUID WITHIN CYCLER.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT WHEN USING DELFLEX 2.5%, HE FEELS OVERLY FULL AND DOES NOT COMPLETE TREATMENT. WHEN USING DELFLEX 1.5%, HE DOES NOT EXPERIENCE THESE ISSUES. TECHNICAL SUPPORT REVIEWED TREATMENT RECORDS AND IT WAS NOTED THAT THE PATIENT EXPERIENCED IIPV (INCREASED INTRAPERITONEAL VOLUME). THE CYCLER WILL BE REPLACED. UPON FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS REPORTED THAT THE PATIENT IS CURRENTLY FEELING WELL AND EXPERIENCING BLOATING SYMPTOMS. THE PATIENT CONTINUES WITH PERITONEAL DIALYSIS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151484 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1