BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 24381670 · Received February 18, 2026

    Report

    Report Number
    0008030665-2026-00353
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 14, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K222318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    PLANT INVESTIGATION: 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 CONTACT STATED AFTER NOTICING THE FLUID THEY WERE NOT ABLE TO CLOSE THE CASSETTE DOOR (THEY HAD PRESSED NEXT). THEY REBOOTED THE CYCLER AND ENCOUNTERED A MWD WATCHDOG TIMER ERROR ALARM. A FLUID LEAK WAS NOTICED WHEN REMOVING THE CASSETTE ON STEP 9 OF TREATMENT. THE PATIENT WAS CONNECTED DURING INCIDENT AND FLUID WAS FOUND ON THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR. NO ALARM WAS NOTED PRIOR TO THE FLUID LEAK. THE CONTACT STATED THE CASSETTE/TUBING DID NOT LOOK LIKE IT HAD ANY HOLES OR TEARS IN IT. THE MWD - WATCHDOG TIMER ERROR ALARM OCCURRED TWICE ON POWER UP. THE CONTACT ALSO NEEDED HELP WITH HOW TO GET THE CASSETTE DOOR TO CLOSE SINCE DOOR WAS STILL OPEN. THE CYCLER WAS REBOOTED AND THE PATIENT ALSO DISCONNECTED AND RECONNECTED THE POWER CORD AND THE ALARM CLEARED. THE PATIENT WAS ABLE TO CLOSE THE DOOR ON THE READY SCREEN AND WAS ADVISED TO WAIT 1 DAY BEFORE USING THE CYCLER AGAIN. THE CONTACT WAS ASKING IF THEY COULD CONTINUE USING CYCLER TONIGHT AND WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). UPON FOLLOW-UP, THE PDRN STATED A FLUID LEAK WAS DISCOVERED DURING STEP 9 - END OF TREATMENT AFTER TREATMENT WAS COMPLETED AND WHEN THE PATIENT CONTACT OPENED THE CASSETTE DOOR. THE CASSETTE DOOR WAS OPENED AND FLUID WAS DISCOVERED LEAKING FROM THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR, IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE FILM ON THE BACK OF THE CASSETTE APPEARED INTACT AND THE FLUID LEAKED FROM AN UNKNOWN LOCATION. THE PATIENT WAS ABLE TO REVERT TO MANUALS TO COMPLETE TREATMENT ON THE NIGHT OF THE REPORTED EVENT. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PDRN ALLOWED FOR THE CYCLER CASSETTE AREA TO DRY AND HAS RESUMED TREATMENT USING THE CYCLER WITHOUT FURTHER ISSUE. THE PDRN STATED THE CYCLER SET (CASSETTE) USED WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACT STATED AFTER NOTICING THE FLUID THEY WERE NOT ABLE TO CLOSE THE CASSETTE DOOR (THEY HAD PRESSED NEXT). THEY REBOOTED THE CYCLER AND ENCOUNTERED A MWD WATCHDOG TIMER ERROR ALARM. A FLUID LEAK WAS NOTICED WHEN REMOVING THE CASSETTE ON STEP 9 OF TREATMENT. THE PATIENT WAS CONNECTED DURING INCIDENT AND FLUID WAS FOUND ON THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR. NO ALARM WAS NOTED PRIOR TO THE FLUID LEAK. THE CONTACT STATED THE CASSETTE/TUBING DID NOT LOOK LIKE IT HAD ANY HOLES OR TEARS IN IT. THE MWD - WATCHDOG TIMER ERROR ALARM OCCURRED TWICE ON POWER UP. THE CONTACT ALSO NEEDED HELP WITH HOW TO GET THE CASSETTE DOOR TO CLOSE SINCE DOOR WAS STILL OPEN. THE CYCLER WAS REBOOTED AND THE PATIENT ALSO DISCONNECTED AND RECONNECTED THE POWER CORD AND THE ALARM CLEARED. THE PATIENT WAS ABLE TO CLOSE THE DOOR ON THE READY SCREEN AND WAS ADVISED TO WAIT 1 DAY BEFORE USING THE CYCLER AGAIN. THE CONTACT WAS ASKING IF THEY COULD CONTINUE USING CYCLER TONIGHT AND WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). UPON FOLLOW-UP, THE PDRN STATED A FLUID LEAK WAS DISCOVERED DURING STEP 9 - END OF TREATMENT AFTER TREATMENT WAS COMPLETED AND WHEN THE PATIENT CONTACT OPENED THE CASSETTE DOOR. THE CASSETTE DOOR WAS OPENED AND FLUID WAS DISCOVERED LEAKING FROM THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR, IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE FILM ON THE BACK OF THE CASSETTE APPEARED INTACT AND THE FLUID LEAKED FROM AN UNKNOWN LOCATION. THE PATIENT WAS ABLE TO REVERT TO MANUALS TO COMPLETE TREATMENT ON THE NIGHT OF THE REPORTED EVENT. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PDRN ALLOWED FOR THE CYCLER CASSETTE AREA TO DRY AND HAS RESUMED TREATMENT USING THE CYCLER WITHOUT FURTHER ISSUE. THE PDRN STATED THE CYCLER SET (CASSETTE) USED WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365486 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 63 YR Female LIBERTY CYCLER SET.| LIBERTY CYCLER SET.| PD SOLUTION.| PD SOLUTION.