BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 17760913 · Received September 15, 2023

    Report

    Report Number
    0002937457-2023-01433
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    June 12, 2023
    Report Date
    September 15, 2023
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SIGNS OF PHYSICAL DAMAGE.TOUCH SCREEN TEST FAILED - WHEN POWERING ON THE CYCLER THE ¿OK, STOP, AND UP/DOWN ARROWS PUSH BUTTONS¿ ILLUMINATED, HOWEVER THE FRONT PANEL TOUCH SCREEN REMAINED DIM. VOLTAGE CHECK PASSED. CHECK/JOSTLE THE DC POWER CABLE, WHEN JOSTLING THE DC CONNECTOR AT THE BACKPLANE BOARD, AND THERE WERE NO FLUCTUATIONS OBSERVED WITH 5 VOLT DISPLAY AND MEASURED VALUES. REPLACED DC POWER CABLE AND A PRE-AST 15MINS 1000ML SIMULATED TREATMENT PERFORMED AND PASSED. SYSTEM AIR LEAK PASSED. THE INTERNAL INSPECTION OF THE CYCLER SHOWED THAT THERE WAS EVIDENCE OF AN INTERNAL SHORT PRESENT ON TRANSFORMER (T1) OF 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 TOUCH SCREEN BECAME OPERATIONAL. REMOVED FUNCTIONING INVERTER BOARD FROM THE TOUCH SCREEN AT THE COMPLETION OF THE INVESTIGATION. 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 SYSTEM ERROR UNEXPECTED RESET ALARM DURING AN UNKNOWN PHASE/CYCLE OF PD TREATMENT. THE ALARM OCCURRED TWICE. THE TECHNICAL SUPPORT REPRESENTATIVE ISSUED A CYCLER REPLACEMENT AND ADVISED THE PATIENT TO CONTACT PDRN TO INFORM OF REPLACEMENT. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT VIA MANUAL EXCHANGES 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. ALARM OCCURRED TWICE TODAY. REFER TO QSN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779066 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

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