BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 3811818 · Received March 10, 2014

    Report

    Report Number
    3811818
    Event Type
    Death
    Date Received
    March 10, 2014
    Date of Event
    January 27, 2014
    Report Date
    February 5, 2014
    Manufacturer
    FRESENIUS USA INC.
    Product Code
    FKX
    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 (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 (B)(6) 2014. MFR REF #2937457-2014-00357.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143664 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS USA INC. LC012020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death FRESENIUS DALFLEX SOLUTION| FRESENIUS STAY SAFE CYCLER SETS