BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 17914387 · Received October 11, 2023

    Report

    Report Number
    0002937457-2023-01546
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    July 3, 2023
    Report Date
    October 11, 2023
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL INSPECTION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. PLUG UNIT IN, POWER UP CHECK FAILED. UPON START UP CYCLER WOULD POWER OFF DUE TO SHORT CAUSED BY EXPOSED METAL ON HEATER TRAY CONNECTER. REPLACED HEATER TRAY. CYCLER NOW FUNCTIONS AS DESIGNED. HEATER TEST FAILED. ALL THERMISTORS OUT OF SPECIFICATION. FAILURE TRACED TO I/O BOARD. REPLACED I/O BOARD. THERMISTORS NOW WITHIN RANGE. ENCOUNTERED M21-13 THERMISTOR ALARM. FAILURE TRACED TO EXPOSED METAL ON HEATER TRAY CABLE. REPLACED HEATER TRAY CABLE. VALVE ACTUATION TEST PASSED. SYSTEM AIR LEAK TEST PASSED. POST-AST 2HOURS 15MINS 8500ML SIMULATED TREATMENT WAS PERFORMED WITHOUT ANY FAILURES OR PROBLEMS. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED NO DISCREPANCIES. THE DEVICE HISTORY RECORD DID REVEAL ISSUES OR PROBLEMS RELATED TO THE REPORTED SYMPTOM CODE(S). FRONT HEATER TRAY ASSEMBLY REPLACED ON (B)(6) 2023. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT CAUSED BY AN EXPOSED CABLE.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT A M69 SOLUTION TEMPERATURE HIGH ALARM ON THE LIBERTY SELECT CYCLER. INCIDENT OCCURRED ONE TIME. THE ALARM WAS ENCOUNTERED AS SOON AS THE PATIENT POWERED THE CYCLER ON. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE REQUESTED THE PATIENT REBOOT THE CYCLER. THE PATIENT THEN ENCOUNTERED THE MWD ¿ WATCHDOG TIMER ERROR ALARM IN POWER UP. THE ALARM OCCURRED ONE TIME AFTER REBOOT. THE PATIENT WAS NOT CONNECTED DURING INCIDENT. THE FRESENIUS REPRESENTATIVE ASSISTED IN GETTING THE CYCLER REPLACED DUE TO MWD. THE LAST TREATMENT COMPLETED USING CURRENT CYCLER WAS ON 7/1/23. TECH SUPPORT ADVISED TO DISCONTINUE USE OF THIS CYCLER. UPON REVIEW OF A LETTER IT WAS DETERMINED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITHOUT ANY ADVERSE EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629342 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown