BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 24531743 · Received March 6, 2026

    Report

    Report Number
    0008030665-2026-00457
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 6, 2026
    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
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING THE LIBERTY SELECT CYCLER AND THE ADVERSE EVENT OF PERITONITIS, CHARACTERIZED BY ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. IT IS WELL ESTABLISHED THAT PD PATIENTS ARE AT HIGH RISK FOR PERITONEUM INFECTIONS. THE ROOT CAUSE OF THIS PATIENT¿S PERITONITIS CANNOT BE DETERMINED; HOWEVER, THERE WAS NO INDICATION OF A CONTRIBUTING MALFUNCTION OR DEFICIENCY OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) AS REPORTED BY A MEDICAL PROFESSIONAL. THOUGH DIAGNOSTIC LABORATORY RESULTS WERE NOT REPORTED, A REDUCTION IN SYMPTOMS IN RESPONSE TO ANTIBIOTIC THERAPY PROVIDED EVIDENCE OF A RESOLVING PERITONITIS INFECTION. THEREFORE, THE LIBERTY SELECT CYCLER CAN BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO ALLEGATION OR OBJECTIVE EVIDENCE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENT THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    THE PERITONEAL DIALYSIS (PD) PATIENT CONTACT REPORTED TO FRESENIUS THAT THE PATIENT WAS HOSPITALIZED AND WOULD LIKELY TRANSFER TO HEMODIALYSIS (HD) THERAPY UPON DISCHARGE. DURING INITIAL FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH PERITONITIS. UPON FOLLOW-UP WITH THE PATIENT¿S PD NURSE, IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED ON (B)(6)2026 FOR A SMALL BOWEL OBSTRUCTION (SBO) AND ABDOMINAL PAIN WITH CLOUDY PERITONEAL EFFLUENT FLUID. IT WAS AFFIRMED THAT THE SBO WAS DUE TO UNRELATED COMORBIDITIES. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT OBTAINED AND TESTED IN THE HOSPITAL PRESENTED WITH NO GROWTH IN THE CULTURE AND AN ELEVATED WBC COUNT (EXACT COUNT NOT REPORTED). ALONG WITH THE SBO, THE PATIENT WAS ALSO DIAGNOSED WITH PERITONITIS DUE TO AN UNKNOWN ETIOLOGY. THE PATIENT WAS PRESCRIBED INTRAVENOUS ANTIBIOTICS (TYPES AND DOSAGES UNKNOWN) TO ADDRESS THE INFECTION WHILE HOSPITALIZED. THE PATIENT¿S PD CATHETER WAS REMOVED DUE TO THE NATURE OF INFECTION, AND THEY WERE TRANSITIONED TO HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY ON A HOSPITAL PROVIDED HD DEVICE (UNKNOWN BRAND AND MODEL) FOR THE DURATION OF THE ADMISSION. THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY ON 3/MAR/2026 WHERE THEY CONTINUE HD THERAPY THROUGH AN OUTSIDE SERVICE. IT WAS REPORTED THAT THE PATIENT¿S SBO, PERITONITIS AND THE ASSOCIATED HOSPITALIZATION WERE NOT THE RESULT OF A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT IS RECOVERING FROM THIS EVENT AND THEY WILL CONTINUE HD THERAPY ON AN IN-CENTER BASIS UPON DISCHARGE WITH NO PLAN TO RETURN TO PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596727 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 86 YR Female Required Intervention| H DELFLEX PD FLUID| LIBERTY CYCLER SET