BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 21113664 · Received January 9, 2025

    Report

    Report Number
    0008030665-2025-00076
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    January 1, 2024
    Report Date
    October 13, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K222318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: A TEMPORAL RELATIONSHIP DOES NOT EXIST BETWEEN CCPD THERAPY UTILIZING THE LIBERTY SELECT CYCLER AND THE PATIENT¿S ADVERSE EVENT OF A VENTRAL HERNIA AS HE WAS DIAGNOSED PRIOR TO HIS START ON PD THERAPY. IT IS WELL ESTABLISHED THAT THOSE PATIENTS UNDERGOING PD THERAPY ARE AT HIGH RISK FOR MECHANICAL COMPLICATION DUE TO HERNIAS OF ANY ETIOLOGY AND MAY BE SAFELY REPAIRED TO CONTINUE SUCCESSFUL PD THERAPY. THE CAUSE OF THIS PATIENT¿S INJURY CANNOT BE DETERMINED; HOWEVER, IT WAS CONFIRMED THAT THE PATIENT¿S HERNIA WAS NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) AS REPORTED BY A MEDICAL PROFESSIONAL. THIS IS FURTHER SUPPORTED BY STUDIES THAT HAVE FOUND MOST HERNIAS OCCUR PRIOR TO THE PATIENT¿S START ON PD. THEREFORE, THE LIBERTY SELECT CYCLER CAN BE EXCLUDED AS A ROOT CAUSE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. BASED ON THE REQUIRED INFORMATION, THOUGH AN ALLEGATION EXISTS BY THE PATIENT THAT STATED PD FLUID CAUSED HIS HERNIA, THERE IS NO OBJECTIVE EVIDENCE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER REPORTED TO FRESENIUS HE WAS HOSPITALIZED FOR A SMALL BOWEL OBSTRUCTION (SBO) ATTRIBUTED TO A PRIOR HERNIA SURGERY. THERE WAS NO SPECIFIC ALLEGATION THIS EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT UNDERWENT PROCEDURES FOR AN OUTPATIENT VENTRAL HERNIA REPAIR ON (B)(6) 2024 AND AN INPATIENT PROCEDURE FOR A SMALL BOWEL OBSTRUCTION ON (B)(6) 2024. THE PATIENT WAS DIAGNOSED WITH A VENTRAL HERNIA ON AN UNKNOWN DATE PRIOR TO HIS START ON CCPD THERAPY IN (B)(6) 2024. THE PATIENT HAD A SUCCESSFUL REPAIR PROCEDURE AND CONTINUED CCPD THERAPY AT LOWER FILL VOLUMES ON THE SAME LIBERTY SELECT CYCLER AS BEFORE. THE PATIENT BEGAN TO EXPERIENCE ABDOMINAL PAIN ON (B)(6) 2024 AND HE WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY. THE PATIENT UNDERWENT A CORRECTIVE PROCEDURE FOR AN SBO ON 24/DEC/2024 WHILE HOSPITALIZED AS IT WAS DETERMINED THE SBO WAS THE ROOT CAUSE OF THE ABDOMINAL PAIN. IT WAS EXPLAINED THE SBO WAS A COMPLICATION FROM THE HERNIA PROCEDURE AND NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). IT WAS UNKNOWN WHETHER CCPD EXACERBATED THE PATIENT¿S HERNIA OVER THE COURSE OF NORMAL THERAPY, BUT IT WAS AFFIRMED HE HAD NOT COMPLAINED OF PAIN OR ANY RESULTING SYMPTOMS BEFORE THE SBO. THE MODALITY OF DIALYSIS THE PATIENT UTILIZED DURING THIS ADMISSION WAS UNKNOWN; HOWEVER, IT WAS ASSUMED PD THERAPY INVOLVED MANUAL EXCHANGES WHICH HISTORICALLY HAS BEEN THE PREFERENCE FOR RENAL REPLACEMENT THERAPY IN THE ADMITTING FACILITY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. IT WAS CONFIRMED THAT THE PATIENT¿S VENTRAL HERNIA, SBO, THE ASSOCIATED PROCEDURES AND HOSPITALIZATION WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT CONTINUES CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER THROUGHOUT THESE EVENTS TO THE PRESENT WITH DECREASED FILL VOLUMES TO SUPPORT HEALING FROM THE SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER REPORTED TO FRESENIUS HE WAS HOSPITALIZED FOR A SMALL BOWEL OBSTRUCTION (SBO) ATTRIBUTED TO A PRIOR HERNIA SURGERY. THERE WAS NO SPECIFIC ALLEGATION THIS EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT UNDERWENT PROCEDURES FOR AN OUTPATIENT VENTRAL HERNIA REPAIR ON (B)(6) 2024 AND AN INPATIENT PROCEDURE FOR A SMALL BOWEL OBSTRUCTION ON (B)(6) 2024. THE PATIENT WAS DIAGNOSED WITH A VENTRAL HERNIA ON AN UNKNOWN DATE PRIOR TO HIS START ON CCPD THERAPY IN (B)(6) 2024. THE PATIENT HAD A SUCCESSFUL REPAIR PROCEDURE AND CONTINUED CCPD THERAPY AT LOWER FILL VOLUMES ON THE SAME LIBERTY SELECT CYCLER AS BEFORE. THE PATIENT BEGAN TO EXPERIENCE ABDOMINAL PAIN ON (B)(6) 2024 AND HE WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY. THE PATIENT UNDERWENT A CORRECTIVE PROCEDURE FOR AN SBO ON (B)(6) 2024 WHILE HOSPITALIZED AS IT WAS DETERMINED THE SBO WAS THE ROOT CAUSE OF THE ABDOMINAL PAIN. IT WAS EXPLAINED THE SBO WAS A COMPLICATION FROM THE HERNIA PROCEDURE AND NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). IT WAS UNKNOWN WHETHER CCPD EXACERBATED THE PATIENT¿S HERNIA OVER THE COURSE OF NORMAL THERAPY, BUT IT WAS AFFIRMED HE HAD NOT COMPLAINED OF PAIN OR ANY RESULTING SYMPTOMS BEFORE THE SBO. THE MODALITY OF DIALYSIS THE PATIENT UTILIZED DURING THIS ADMISSION WAS UNKNOWN; HOWEVER, IT WAS ASSUMED PD THERAPY INVOLVED MANUAL EXCHANGES WHICH HISTORICALLY HAS BEEN THE PREFERENCE FOR RENAL REPLACEMENT THERAPY IN THE ADMITTING FACILITY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. IT WAS CONFIRMED THAT THE PATIENT¿S VENTRAL HERNIA, SBO, THE ASSOCIATED PROCEDURES AND HOSPITALIZATION WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT CONTINUES CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER THROUGHOUT THESE EVENTS TO THE PRESENT WITH DECREASED FILL VOLUMES TO SUPPORT HEALING FROM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352563 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 65 YR Male Hospitalization| R DELFLEX PD FLUID| LIBERTY CYCLER SET