BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 18695213 · Received February 13, 2024

    Report

    Report Number
    0002937457-2024-00254
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    November 17, 2023
    Report Date
    February 13, 2024
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 SIGN OF PHYSICAL DAMAGE. FUNCTIONAL DISPLAY TEST FAILED. THE SCREEN WAS DIM UPON POWERING ON THE CYCLER. VOLTAGE CHECK PASSED. TEACH PUMPS TEST PASSED. THE SIMULATED TREATMENT POST-ACCELERATED STRESS TEST PASSED. DURING INTERNAL INSPECTION IT WAS FOUND THAT TRANSFORMER (T1) ON THE ¿INVERTER BOARD¿ HAD AN INTERNAL SHORT WHICH CAUSED A DIM DISPLAY. A KNOWN WORKING INVERTER BOARD WAS INSTALLED AND THE DISPLAY FUNCTIONED AS INTENDED. REMOVED FUNCTIONING INVERTER BOARD FROM THE DISPLAY AT THE COMPLETION OF THE INVESTIGATION. THERE WERE NO OTHER VISUAL DISCREPANCIES FOUND DURING THE INTERNAL INSPECTION. 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 ON TRANSFORMER ON THE INVERTER BOARD. THE CYCLER WAS REFURBISHED FOLLOWING THE EVALUATION.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THAT PATIENT WAS TURNING ON CYCLER TO SETUP FOR TREATMENT AND RECEIVED THE ALARM CODE "MWD WATCHDOG TIMER ERROR" AFTER A SUCCESSFUL REBOOT OF CYC. PATIENT THEN RECEIVED A "M01-4" ON STEP 1 OF SETUP, WHEN PRESSING "OK" DID NOT CLEAR MESSAGED AND REBOOTED CYC AGAIN. ON "READY SCREEN" PATIENT THEN RECEIVED A "M01-7", PATIENT THEN STATED THAT WHILE HE WAS ON HOLD HE REBOOTED THE CYC FOR A THIRD TIME AND RECEIVED A "M01-8" ON THE "READY SCREEN". ISSUE: MWD - WATCHDOG TIMER ERROR ALARM OCCURRED IN POWER UP, ONCE ON READY SCREEN IT GOES TO THE "WATCH DOG TIMER ERROR". ALARM OCCURRED TODAY FOR THE FIRST TIME, PATIENT WAS NOT CONNECTED DURING INCIDENT. TURNED OFF CYCLER, UNPLUGGED FROM WALL OUTLET, THEN PLUGGED BACK IN AND REBOOT CYCLER. ALARM DID NOT REOCCUR BUT PATIENT NOW RECEIVED A "M01-4 ON STEP 1 OF SETUP. ISSUE: M01-4 CANNOT READ NON-INVERTED INPUT SIGNAL WARNING OCCURRED IN STEP 1 OF SETUP BEFORE CASSETTE INSERTED, WARNING OCCURRED ONCE TODAY AFTER RECEIVING A WATCH DOG TIMER ERROR. PATIENT WAS NOT CONNECTED, REBOOTED CYCLER FOR SECOND TIME AND WARNING DID NOT REOCCUR BUT PT HAS NOW RECEIVED AN M01-7. ISSUE: M01-7 CANNOT READ INTERNAL TEMPERATURE WARNING OCCURRED IN READY, WARNING OCCURRED ONCE AFTER REBOOT OF CYCLER AFTER RECEIVING M01-4 AND WATCH DOG TIMER. PATIENT WAS NOT CONNECTED, WHILE PATIENT WAS ON HOLD, HE STATED THAT HE REBOOTED CYCLER FOR THE THIRD TIME AND ON THE "READY SCREEN" HE RECEIVED A "M01-8". ISSUE: M01-8 CANNOT READ MOTOR POSITION SENSOR WARNING OCCURRED ON "READY SCREEN", WARNING OCCURRED ONCE AFTER THREE REBOOTS OF CYCLER AND AFTER RECEIVING A MWD WATCHDOG TIMER ERROR, M01-4 AND M01-7. PATIENT WAS NOT CONNECTED. TECHNICAL SUPPORT REPLACED CYCLER DUE TO M01-8 CANNOT READ MOTOR POSITION SENSOR, ADVISED TO INFORM NURSE OF REPLACEMENT AND TO DISCONTINUE USE OF THIS CYCLER. TIME OF ARRIVAL FOR NEW CYCLER 11/18/2023. PATIENT RECEIVED CYCLER REPLACEMENT AND THE CYCLER WAS RETURNED TO THE MANUFACTURER. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THE TRANSFORMER ON THE INVERTER BOARD HAD AN INTERNAL SHORT. A PHONE CALL AND A WRITTEN ATTEMPT HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, BUT FRESENIUS HAS NOT RECEIVED ANY FURTHER DETAILS REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810207 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown