BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 21384432 · Received February 14, 2025

    Report

    Report Number
    0008030665-2025-00366
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 14, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    PMA / PMN Number
    K222318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 SIGNS OF PHYSICAL DAMAGE. THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WERE NO VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. HEATER TRAY TEST PASSED. HEATER SAFETY TEST PASSED. SYSTEM AIR LEAK TEST PASSED. TEACH PUMP TEST PASSED. A PRE-ACCELERATED STRESS TEST SIMULATED TREATMENT WAS PERFORMED AND ENCOUNTERED M67 (FLUID TEMP OUT OF RANGE ALARM) ALARM. FAILURE TRACED TO: BLOWN F1 FUSE ON THE AC DISTRIBUTION BOARD CAUSING THE THERMISTORS TO BE UNABLE TO ACTIVATE AND MAKING AN ELECTRICAL NOISE. REPLACED AC DISTRIBUTION BOARD AND LIBERTY CYCLER WAS ABLE TO COMPLETE THE TREATMENT. AN INTERNAL VISUAL OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID ON THE BOTTOM COVER BEHIND THE FRONT PANEL ASSEMBLY. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. THERE WERE NO DISCREPANCIES ENCOUNTERED WITH THE MUSHROOM HEADS. 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 A BLOWN F1 FUSE ON THE AC DISTRIBUTION 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 A M67 FLUID TEMPERATURE OUT OF RANGE ALARM AND A NOISE ON THE LIBERTY SELECT CYCLER. ISSUE OCCURRED IN STEP 5 OF SETUP. IT IS THE 3RD CALL OF THE NIGHT (QSN (B)(6)). PATIENT WAS NOT CONNECTED DURING INCIDENT. CYCLER WAS NOT NEAR A COOL/HEATING SOURCE. HEATER BAG CAME IN CONTACT WITH HEATER TRAY. HEATER BAG WAS ON THE HEATER TRAY. BAGS WERE NOT PLACED IN MICROWAVE OR OTHER HEATING SOURCE PRIOR TO SETTING UP. ROOM WAS ROOM TEMPERATURE (70F). ISSUE: NOISE OCCURRED IN END PHASE OF THE TREATMENT. THE NOISE SOUNDED LIKE ELECTRICAL NOISE AND HAS BEEN OCCURRING FOR MORE THAN 2 WEEKS. CYCLER WAS SITTING ON A LIBERTY CART. THE CAP OF THE SOLUTION BAG WAS GREEN. THE SIZE OF THE SOLUTION BAG(S) WERE TWO OF 6 LITERS AND 3 LITERS. SUPPLIES ARE FROM THE MOST RECENT DELIVERY. AT LEAST ONE FULL TREATMENT HAS BEEN COMPLETED WITH THIS CYCLER. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ISSUED A REPLACEMENT CYCLER AND ADVISED TO DISCONTINUE THE USE OF THE CURRENT CYCLER. THE ESTIMATED TIME OF ARRIVAL IS 1/11 AND THE SCHEDULED PICK UPDATE IS 1/16. THE PATIENT WILL PERFORM CAPD/MANUALS, UNTIL THE NEW CYCLER ARRIVES. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED. UPON FOLLOW UP, IT WAS DETERMINED THERE WERE NO PATIENT ADVERSE EVENTS AND NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS ABLE TO COMPLETE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414792 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown