BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 12796409 · Received November 11, 2021

    Report

    Report Number
    2937457-2021-02262
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    August 29, 2021
    Report Date
    November 11, 2021
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE NO VISUAL INDICATION OF PARTICULATES WITHIN THE CASSETTE AREA. ENCOUNTERED WATCHDOG ALARM UPON REBOOTING CYCLER AFTER COMPLETING SIMULATED TREATMENT. THE FAILURE WAS DUE TO COLD SOLDER/POOR SOLDER JOB ON THE TERMINAL OF CAPACITOR 8 (C8) OF THE FUNCTIONAL BOARD. DURING THE INTERNAL VISUAL INSPECTION, A SHORTED CONNECTOR ON THE INVERTER BOARD WAS ENCOUNTERED DUE TO A LOOSE PIN ON THE TERMINAL FROM THE J2 CONNECTOR HOUSING PLUG. THERE WERE VISUAL INDICATIONS OF DRIED FLUID ON THE BOTTOM COVER UNDERNEATH THE PUMP ASSEMBLY. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THERE WERE DISCREPANCIES ENCOUNTERED WITH THE MUSHROOM HEADS. BOTH MUSHROOM HEAD A AND B WERE FOUND TO BE INSTALLED CROSS THREADED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT DUE TO A LOOSE PIN ON THE TERMINAL FROM THE J2 CONNECTOR HOUSING PLUG ON THE INVERTER BOARD. THE CYCLER WAS REFURBISHED FOLLOWING THE EVALUATION.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CARETAKER REPORTED VIA PHONE THAT THE PATIENT¿S LIBERTY CYCLER EXPERIENCED MWD ¿ WATCHDOG TIMER ERROR ALARM OCCURRED IN POWER UP. CARETAKER REBOOTED CYCLER TWICE AND MESSAGE REOCCURRED EACH TIME. REPLACED CYCLER DUE TO MWD ¿ WATCHDOG TIMER ERROR. THE ISSUE OCCURRED PRIOR TO TREATMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM, OR ADVERSE EVENT ASSOCIATED WITH THE EVENT. THE CYCLER IS AVAILABLE FOR RETURN AND WAS REPLACED. A PHONE CALL AND WRITTEN ATTEMPT HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, BUT FRESENIUS HAS NOT RECEIVED ANY FURTHER DETAILS REGARDING THE REPORTED EVENT. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THE TRANSFORMER ON THE INVERTER BOARD HAD AN INTERNAL SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691479 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DELFLEX PD FLUID.| LIBERTY CYCLER SET.