BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 18832743 · Received March 4, 2024

    Report

    Report Number
    0002937457-2024-00380
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    November 5, 2023
    Report Date
    March 4, 2024
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED SIGNS OF PHYSICAL DAMAGE ON THE POWER ENTRY MODULE. REPLACED POWER ENTRY MODULE FOR FURTHER TESTING. TOUCH SCREEN TEST FAILED - WHEN POWERING ON THE CYCLER THE ¿OK, STOP, AND UP/DOWN ARROWS PUSH BUTTONS¿ ILLUMINATED, HOWEVER THE FRONT PANEL DISPLAY REMAINED DIM. AN INTERNAL INSPECTION OF THE CYCLER FOUND A SHORT ON THE INVERTER BOARD. THE INVERTER BOARD IS LOCATED ON THE REAR OF THE FRONT PANEL ASSEMBLY. A KNOWN GOOD INVERTER BOARD WAS INSTALLED AND THE DISPLAY BECAME OPERATIONAL. REMOVED FUNCTIONING INVERTER BOARD FROM THE FRONT PANEL AT THE COMPLETION OF THE INVESTIGATION. POST-AST 2HOURS 15MINS 8500ML SIMULATED TREATMENT WAS PERFORMED WITHOUT ANY FAILURES OR PROBLEMS. VOLTAGE VERIFICATION CHECK PASSED. THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ISSUES OR PROBLEMS RELATED TO THE REPORTED SYMPTOM CODE(S).UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT ON THE INVERTER BOARD.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A MWD - WATCHDOG TIMER ERROR ALARM ON THE CYCLER. THE ALARM OCCURRED TWICE. THE PATIENT REBOOTED THE CYCLER AND THE ALARM REOCCURRED. REPLACED CYCLER DUE TO MWD- WATCHDOG TIMER ERROR ALARM. PATIENT DOES KNOW HOW TO PERFORM MANUAL TREATMENTS. THE TECHNICAL SUPPORT REPRESENTATIVE ISSUED THE CYCLER REPLACEMENT. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE REPORTED DAY. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CYCLER WAS RETURNED TO THE MANUFACTURER AND A REPLACEMENT CYCLER WAS PROVIDED AND RECEIVED. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, EVIDENCE OF AN INTERNAL SHORT ON THE TRANSFORMER ON THE INVERTER BOARD WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583054 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown