BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 3796776 · Received May 2, 2014

    Report

    Report Number
    3796776
    Event Type
    Death
    Date Received
    May 2, 2014
    Date of Event
    January 27, 2014
    Report Date
    February 5, 2014
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERITONEAL DIALYSIS PT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS FROM (B)(6) 2014, TESTED POSITIVE FOR FUNGAL PERITONITIS SAMPLE COLLECTED ON (B)(6) /2014. PERITONEAL CATHETER WAS REMOVED. NOTIFIED BY FACILITY OF FINAL RESULT WAS CANDIDA TROPICALIS ON (B)(6) 2014. PT WAS PLACED IN COMFORT CARE AND EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263842 FRESENIUS LIBERTY CYCLER CYCLER KDJ FRESENIUS USA, INC.
    263843 FRESENIUS STAY SAFE CYCLER SETS CYCLER SETS KDJ FRESENIUS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death FRESENIUS DELFLEX SOLUTION 2.5% DEXTROSE,| EXP DATE: 02/2015, NDC# (B)(4)| DOSE: 12.5L OVERNIGHT CYCLING, LOT# 13KU01079,