BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 23771587 · Received December 10, 2025

    Report

    Report Number
    0008030665-2025-02973
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 25, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT A FLUID LEAK WAS DISCOVERED DURING FILL 1 OF A PD TREATMENT. IN A FOLLOW UP, THE PATIENT SAID THERE WAS AN ¿AIR DETECTED IN CASSETTE¿ WARNING. WHEN PATIENT PROCEEDED TO CHANGE THE CASSETTE TO PERFORM A RESET-UP, PATIENT NOTICED FLUID LEAKING AND DRIPPING DOWN FROM THE MACHINE. AFTER REMOVING THE CASSETTE EVERYTHING WAS WET, WITH MOST OF THE FLUID LEAKING INTO THE MACHINE. THE PATIENT ALSO OBSERVED SOME AIR BUBBLES IN THE PATIENT LINE. THE PATIENT DRIED THE CYCLER AND STARTED THE NEXT TREATMENT, WHICH WAS SUCCESSFULLY COMPLETED. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONFIRMED THAT THE LIBERTY CYCLER SET USED DURING THE EVENT (QSN CE00168812) IS AVAILABLE TO RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. PATIENT IS USING SAME CYCLER.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT A FLUID LEAK WAS DISCOVERED DURING FILL 1 OF A PD TREATMENT. IN A FOLLOW UP, THE PATIENT SAID THERE WAS AN ¿AIR DETECTED IN CASSETTE¿ WARNING. WHEN PATIENT PROCEEDED TO CHANGE THE CASSETTE TO PERFORM A RESET-UP, PATIENNT NOTICED FLUID LEAKING AND DRIPPING DOWN FROM THE MACHINE. AFTER REMOVING THE CASSETTE EVERYTHING WAS WET, WITH MOST OF THE FLUID LEAKING INTO THE MACHINE.THE PATIENT ALSO OBSERVED SOME AIR BUBBLES IN THE PATIENT LINE. THE PATIENT DRIED THE CYCLER AND STARTED THE NEXT TREATMENT, WHICH WAS SUCCESSFULLY COMPLETED. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONFIRMED THAT THE LIBERTY CYCLER SET USED DURING THE EVENT (QSN CE00168812) IS AVAILABLE TO RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. PATIENT IS USING SAME CYCLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193948 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DELFLEX PD FLUID.| DELFLEX PD FLUID.| LIBERTY CYCLER SET.| LIBERTY CYCLER SET.