BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 18326454 · Received December 14, 2023

    Report

    Report Number
    3023981687-2023-00295
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    October 27, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100736
    PMA / PMN Number
    K173718
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, DURING A FOLLOW UP, A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED TO FRESENIUS THIS PD PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPERIENCED PERITONITIS. 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 PDRN, IT WAS REPORTED THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2023 WITH ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE OUTPATIENT CLINIC ON (B)(6) 2023 PRESENTED WITH STAPHYLOCOCCUS AUREUS IN THE CULTURE AND AN ELEVATED WBC COUNT (EXACT COUNT UNKNOWN). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. UPON INFECTION FOLLOW UP BY THE OUTPATIENT CLINIC, IT WAS DISCOVERED THE PATIENT WAS NOT WEARING A MASK DURING PD TREATMENTS. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT AND PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN AT 2000 MG EVERY FIVE DAYS FOR THREE WEEKS AND IP CEFTAZIDIME AT 2000 MG DAILY FOR TWO WEEKS. THE IP CEFTAZIDIME WAS DISCONTINUED UPON CULTURE RESULTS. THE PATIENT RECOVERED FROM THIS EVENT AS HE REMAINED ASYMPTOMATIC IN RESPONSE TO ANTIBIOTIC THERAPY. IT WAS CONFIRMED THE PATIENT¿S PERITONITIS WAS NOT DUE TO A DEFICIENCY OR MALFUNCTION OR ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT HAS SINCE TRANSITIONED TO IN-CENTER HEMODIALYSIS FOR RENAL REPLACEMENT THERAPY DUE TO A SEVERE PD CATHETER (NOT A FRESENIUS PRODUCT) INFECTION WITH CATHETER REMOVAL (EVENT CAPTURED AND INVESTIGATED IN COMPLAINT FILE C-1163280). THE PATIENT PLANS TO RESUME CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER ONCE CLEARED BY HIS NEPHROLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273576 LIBERTY CYCLER SET, DUAL PATIENT CONNECT SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861100736

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention LIBERTY SELECT CYCLER| PD SOLUTION