BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY SELECT CYCLER

    MDR report key: 8667169 · Received June 4, 2019

    Report

    Report Number
    8667169
    Event Type
    Death
    Date Received
    June 4, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 24, 2019
    Manufacturer
    FRESENIUS
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO AN OUTSIDE HOSP WITH COMPLAINTS OF RIB PAIN AND FOUND TO HAVE PNA, UTI AND PERITONITIS. PT PASSED AWAY ON (B)(6) 2019. PT WAS ADMITTED TO AN OUTSIDE HOSP WITH SYMPTOMS INCLUDING RIB PAIN. THE PT WAS FOUND TO HAVE PNA, UTI AND PERITONITIS. DETAILS OF HER HOSPITALIZATION ARE NOT AVAILABLE AT THIS TIME. THE PT PASSED AWAY ON (B)(6) 2019. PT'S HOME PERITONEAL DIALYSIS CYCLER HAD RECENTLY BEEN EXCHANGED TO THE FRESENIUS LIBERTY MODEL. IT IS UNK AS TO WHAT IF ANY THE SWITCH TO THE NEW MACHINE CONTRIBUTED TO HER DEATH. INFECTIOUS DISEASE HAS REPORTED A SPIKE IN PERITONEAL CASES FOLLOWING THE CHANGE OVER TO THE FRESENIUS LIBERTY CYCLER STARTING IN LATE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461653 LIBERTY SELECT CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS 180343

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death