BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 22782335 · Received August 12, 2025

    Report

    Report Number
    0008030665-2025-01845
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 29, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861102716
    PMA / PMN Number
    K173718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING A LIBERTY CYCLER SET AND THE SERIOUS ADVERSE EVENTS OF PERITONITIS (CHARACTERIZED BY ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID), WHICH REQUIRED ANTIBIOTIC(S) THERAPY. THE PDRN ATTRIBUTED CAUSALITY TO A BREACH IN THE PATIENT¿S ASEPTIC TECHNIQUE. IT IS WELL ESTABLISHED THAT ESRD PATIENTS UNDERGOING PD THERAPY (MANUAL OR CYCLER BASED) FOR RRT ARE AT HIGH RISK FOR INFECTIONS OF THE PERITONEUM. THE PDRN REPORTED THE SERIOUS ADVERSE EVENTS WERE UNRELATED TO THE PATIENT¿S UTILIZATION OF A FRESENIUS DEVICE(S) AND/OR PRODUCT(S). BASED ON THE INFORMATION AVAILABLE, THE PATIENT¿S LIBERTY CYCLER SET CAN BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) CAUSED OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENTS. FURTHERMORE, THERE IS NO REPORT A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) FAILED TO MEET THE USERS¿ EXPECTATIONS AND/OR THE MANUFACTURERS¿ SPECIFICATIONS. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE PATIENT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS LIBERTY CYCLER SETS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION APPROXIMATELY TWO WEEKS AGO. NO ADDITIONAL INFORMATION WAS PROVIDED DURING THE INTAKE PROCESS. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2025 WITH COMPLAINTS OF DRAIN PAIN (ABDOMINAL PAIN). A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS NOT PROVIDED) WERE COLLECTED (NOTED CLOUDY EFFLUENT FLUID DURING HOME EVALUATION), AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY 7 DAYS (8.0-HOUR DWELL) AND CEFTAZIDIME 1000 MG DAILY FOR 14 DAYS. THE PDRN ATTRIBUTED CAUSALITY TO A BREACH OF ASEPTIC TECHNIQUE, AS A HOME EVALUATION REVEALED THE PATIENT FAILED TO WASH THEIR HANDS OR WEAR A MASK WITHOUT PROMPTING. PATIENT EDUCATION WAS PROVIDED ON 5/AUG/2025, AND THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT THE RESULT OF A FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION APPROXIMATELY TWO WEEKS AGO. NO ADDITIONAL INFORMATION WAS PROVIDED DURING THE INTAKE PROCESS. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2025 WITH COMPLAINTS OF DRAIN PAIN (ABDOMINAL PAIN). A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS NOT PROVIDED) WERE COLLECTED (NOTED CLOUDY EFFLUENT FLUID DURING HOME EVALUATION), AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY 7 DAYS (8.0-HOUR DWELL) AND CEFTAZIDIME 1000 MG DAILY FOR 14 DAYS. THE PDRN ATTRIBUTED CAUSALITY TO A BREACH OF ASEPTIC TECHNIQUE, AS A HOME EVALUATION REVEALED THE PATIENT FAILED TO WASH THEIR HANDS OR WEAR A MASK WITHOUT PROMPTING. PATIENT EDUCATION WAS PROVIDED ON (B)(6) 2025, AND THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT THE RESULT OF A FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270545 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861102716

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H DELFLEX PD FLUID| LIBERTY SELECT CYCLER