BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 20514327 · Received October 23, 2024

    Report

    Report Number
    0002937457-2024-01486
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    July 12, 2024
    Report Date
    October 23, 2024
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED SIGNS OF PHYSICAL DAMAGE (CASSETTE DOOR DAMAGED). THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WERE VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA. THERE WERE NOT BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. SCREEN BRIGHTNESS CHECK FAILED. WHEN POWERING ON THE 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 T1 OF THE INVERTER BOARD WITH LOT CODE 2034 WHICH REFLECTS THE TRANSFORMER HAS P155 INSULATION THICKNESS. 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. SYSTEM AIR LEAK TEST PASSED. VALVE ACTUATION TEST PASSED. TEACH PUMP TEST PASSED. ACCELERATED STRESS TEST WAS PERFORMED AND ENCOUNTERED STALLING MOTOR PUMP B. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID UNDER THE PUMP ASSEMBLY ON THE BOTTOM COVER. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. MUSHROOM HEAD CHECK PASSED. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED, AND THE CAUSE WAS DETERMINED TO BE A SHORT ON THE TRANSFORMER OF THE INVERTER BOARD.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) REGISTER NURSE CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH THE M01-17 CANNOT TEACH PUMPS DURING SETUP PHASE ALARM. THE PATIENT STATED THE ALARM HAS BEEN OCCURRING 4 OUT OF 5 DAYS. THE WARNING OCCURRED IN STEP 2 OF SETUP, AND HAD OCCURRED 4 TIMES IN THE LAST 5 DAYS, USING DIFFERENT BOXES OF CASSETTES. THE PATIENT CALLED TWICE REGARDING THE ALARM (SEE QSN (B)(4)). SEE ADDITIONAL FOR DATE 07/08/2024 #(B)(4), AND FOR DATE 06/14/2024 # (B)(4). THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ISSUED A REPLACEMENT CYCLER AND ADVISED TO CONTINUE USE OF THE CURRENT CYCLER. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED. UPON E-MAIL FOLLOW UP RESPONSE, IT WAS CONFIRMED THAT NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE CYCLER AFTER THE EQUIPMENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33155 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown