BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 24903349 · Received April 16, 2026

    Report

    Report Number
    0008030665-2026-00722
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100750
    PMA / PMN Number
    K173718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING A LIBERTY CYCLER SET AND THE SERIOUS ADVERSE EVENT OF PERITONITIS, CHARACTERIZED BY ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID, WHICH WARRANTED ANTIBIOTIC THERAPY. THE PDRN ATTRIBUTED CAUSALITY TO AN UNSPECIFIED TOUCH CONTAMINATION EVENT INVOLVING POOR HAND HYGIENE AFTER UTILIZING THE RESTROOM DURING CCPD THERAPY. IT IS WELL ESTABLISHED THAT END-STAGE RENAL DISEASE (ESRD) PATIENTS UNDERGOING PD THERAPY (MANUAL OR CYCLER BASED) FOR RENAL REPLACEMENT THERAPY (RRT) ARE AT HIGH RISK FOR INFECTIONS OF THE PERITONEUM. ADDITIONALLY, ESCHERICHIA COLI IS ONE OF THE MOST COMMON ORGANISMS CAUSING GRAM-NEGATIVE PERITONITIS IN PD PATIENTS AND IS CONSIDERED NORMAL FLORA OF THE GASTROINTESTINAL TRACT. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE UNRELATED TO ANY FRESENIUS DEVICE(S) AND/OR PRODUCT(S) MALFUNCTION OR DEFICIENCY. BASED ON THE INFORMATION AVAILABLE, THE 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 WAS NO REPORT A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) FAILED TO MEET THE USERS¿ EXPECTATIONS OR THE MANUFACTURERS¿ SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH PERITONITIS AND PRESCRIBED ANTIBIOTICS. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN). THE PDRN STATED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2026 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED AS AN OUTPATIENT WITH INTRAPERITONEAL (IP) VANCOMYCIN 1000 MG EVERY X 1 AND CEFTAZIDIME 1500 MG DAILY FOR 21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR ESCHERICHIA COLI, AND THE PATIENT¿S VANCOMYCIN WAS DISCONTINUED. THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS AND CONTINUES TO UNDERGO CONTINUOUS CYCLIC PD (CCPD) THERAPY AT HOME UTILIZING THE SAME LIBERTY SELECT CYCLER WITHOUT ANY REPORTED ISSUES. THE PDRN ATTRIBUTED CAUSALITY TO AN UNSPECIFIED TOUCH CONTAMINATION EVENT INVOLVING POOR HAND HYGIENE AFTER UTILIZING THE RESTROOM DURING CCPD THERAPY. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337496 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention DELFLEX PD FLUID| LIBERTY SELECT CYCLER