BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 16584498 · Received March 21, 2023

    Report

    Report Number
    0002937457-2023-00420
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    December 19, 2022
    Report Date
    March 21, 2023
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR VISUAL INSPECTION OF THE RETURNED CYCLER SHOWED NO SIGNS OF PHYSICAL DAMAGE. UPON POWER UP, THE CYCLER TOUCH SCREEN TEST FAILED; THE DISPLAY REMAINED DIM. IT WAS IDENTIFIED THAT THE CAUSE FOR THE DIM SCREEN WAS DUE TO AN INTERNAL SHORT PRESENT ON THE TRANSFORMER OF THE INVERTER BOARD. A KNOWN GOOD INVERTER BOARD WAS INSTALLED TO CONTINUE TESTING. A VOLTAGE CHECK WAS PERFORMED AND PASSED. A SIMULATED TREATMENT POST-ACCELERATED STRESS TEST WAS PERFORMED AND PASSED. THE IQ DRIVE SUCCESSFULLY RECORDED THE TREATMENT DATASHEET. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED VISUAL INDICATIONS OF DRIED FLUID WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE ENCOUNTERED DRIED FLUID COULD NOT BE DETERMINED. A MUSHROOM HEAD CHECK WAS PERFORMED AND PASSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND SHOWED THAT THE CYCLER HAD A DIM DISPLAY CAUSED BY A FAILING INVERTER BOARD. THE ISSUE WAS RESOLVED BY REPLACING THE FRONT PANEL ASSEMBLY ON (B)(6) 2022. UPON COMPLETION OF THE EVALUATION, THE DISPLAY BRIGHTNESS PROBLEM WAS CONFIRMED, AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT ON THE TRANSFORMER OF THE INVERTER BOARD.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO TECHNICAL SUPPORT (TS) THAT THEY RECEIVED THE IQ DRIVE NOT DETECTED MESSAGE DURING THE END OF TREATMENT PHASE OF THEIR PD TREATMENT. THE CYCLER SUBSEQUENTLY ALARMED WITH THE MWD ¿ WATCHDOG TIMER ERROR. THE PATIENT TRIED REBOOTING THE CYCLER; HOWEVER, THE MWD ¿ WATCHDOG TIMER ERROR ALARM PERSISTED. AT THAT POINT IN TIME, THE TS REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND A REPLACEMENT CYCLER WAS ISSUED TO THE PATIENT. THE PATIENT WAS ALSO ADVISED TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE REPLACEMENT. IT WAS REPORTED THAT THE PATIENT WOULD PERFORM AN ALTERNATE METHOD OF PD THERAPY. UPON FOLLOW UP, THE PATIENT CONFIRMED THAT THERE WERE NO INJURIES EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT REPORTEDLY COMPLETED THEIR TREATMENT. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. UPON EVALUATION OF THE CYCLER BY THE MANUFACTURER, AN INTERNAL SHORT WAS IDENTIFIED ON THE TRANSFORMER OF THE INVERTER BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356371 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.