BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 22168926 · Received June 9, 2025

    Report

    Report Number
    0008030665-2025-01303
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 22, 2025
    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
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3 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 NO VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WERE 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. SYSTEM AIR LEAK TEST PASSED. VALVE ACTUATION TEST FAILED. FAILURE TRACED TO INTERMITTENT BALLOON VALVE 8. VALVE ACTUATION TEST PASSED. A POST-ACCELERATED STRESS TEST SIMULATED TREATMENT WAS PERFORMED WITHOUT ANY FAILURES OR PROBLEMS. NO FLUID LEAKS WERE FOUND AFTER SIMULATED TREATMENT. THERE WERE NO VISUAL DISCREPANCIES ENCOUNTERED DURING THE INTERNAL INSPECTION. 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, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT RECEIVING ¿M30 BALLOON VALVE LEAK¿ WARNING ON THE LIBERTY SELECT CYCLER. ISSUE OCCURRED IN STEP 5 OF SETUP. PATIENT PRESSED OK AND M30 REOCCURRED. ISSUE OCCURRED MULTIPLE TIMES TONIGHT. PATIENT STATED HE RECEIVED M30 FOR 3 NIGHTS CONSECUTIVELY. PATIENT WAS NOT CONNECTED DURING INCIDENT. CYCLER HAD BEEN RE-SETUP WITH NEW SUPPLIES. FLUID WAS SEEN COMING FROM THE CASSETTE. REPLACED CYCLER DUE TO M30 BALLOON VALVE LEAK. AT LEAST ONE FULL TREATMENT HAD BEEN COMPLETED WITH THIS CYCLER. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED TO DISCONTINUE USE OF THIS CYCLER AND TO CONTACT PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM OF REPLACEMENT. PATIENT ALSO CALL PREVIOUSLY. WHILE TROUBLESHOOTING THE PATIENT STATED THERE WAS FLUID LEAKING FROM THE CASSETTE ONTO THE FLOOR. M30 BALLOON VALVE LEAK WARNING OCCURRED IN STEP 5 OF SETUP. ISSUE OCCURRED 1 TIME THIS EVENING; PATIENT WAS NOT CONNECTED DURING INCIDENT. CYCLER HAD NOT BEEN RE-SETUP WITH NEW SUPPLIES. FLUID WAS SEEN ON THE FLOOR AND WAS LEAKING FROM AN UNKNOWN AREA IN THE TUBING. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED TO RE-SETUP WITH ALL NEW SUPPLIES. PLEASE SEE QSN # (B)(4) FOR REFERENCE. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE THE TREATMENTS ON THE CYCLER. THE CYCLER REPLACEMENT WAS RECEIVED. PATIENT CONFIRMED THAT THE FLUID LEAK WAS COMING FROM THE INSIDE OF THE CASSETTE BUT COULD NOT SPECIFY MORE INFORMATION ABOUT THAT. PATIENT AFFIRMED THAT WHEN ISSUE OCCURRED, HE WAS CONNECTED TO THE CYCLER AND AFTER HE SAW THE FLUID LEAK, HE GOT DISCONNECTED. THERE IS NO PRODUCT FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT RECEIVING ¿M30 BALLOON VALVE LEAK¿ WARNING ON THE LIBERTY SELECT CYCLER. ISSUE OCCURRED IN STEP 5 OF SETUP. PATIENT PRESSED OK AND M30 REOCCURRED. ISSUE OCCURRED MULTIPLE TIMES TONIGHT. PATIENT STATED HE RECEIVED M30 FOR 3 NIGHTS CONSECUTIVELY. PATIENT WAS NOT CONNECTED DURING INCIDENT. CYCLER HAD BEEN RE-SETUP WITH NEW SUPPLIES. FLUID WAS SEEN COMING FROM THE CASSETTE. REPLACED CYCLER DUE TO M30 BALLOON VALVE LEAK. AT LEAST ONE FULL TREATMENT HAD BEEN COMPLETED WITH THIS CYCLER. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED TO DISCONTINUE USE OF THIS CYCLER AND TO CONTACT PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM OF REPLACEMENT. PATIENT ALSO CALL PREVIOUSLY. WHILE TROUBLESHOOTING THE PATIENT STATED THERE WAS FLUID LEAKING FROM THE CASSETTE ONTO THE FLOOR. M30 BALLOON VALVE LEAK WARNING OCCURRED IN STEP 5 OF SETUP. ISSUE OCCURRED 1 TIME THIS EVENING; PATIENT WAS NOT CONNECTED DURING INCIDENT. CYCLER HAD NOT BEEN RE-SETUP WITH NEW SUPPLIES. FLUID WAS SEEN ON THE FLOOR AND WAS LEAKING FROM AN UNKNOWN AREA IN THE TUBING. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED TO RE-SETUP WITH ALL NEW SUPPLIES. PLEASE SEE QSN#: (B)(4) FOR REFERENCE. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE THE TREATMENTS ON THE CYCLER. THE CYCLER REPLACEMENT WAS RECEIVED. PATIENT CONFIRMED THAT THE FLUID LEAK WAS COMING FROM THE INSIDE OF THE CASSETTE BUT COULD NOT SPECIFY MORE INFORMATION ABOUT THAT. PATIENT AFFIRMED THAT WHEN ISSUE OCCURRED, HE WAS CONNECTED TO THE CYCLER AND AFTER HE SAW THE FLUID LEAK, HE GOT DISCONNECTED. THERE IS NO PRODUCT FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332795 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 Unknown LIBERTY CYCLER SET.| LIBERTY CYCLER SET.| PD SOLUTION.| PD SOLUTION.