BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 3952300 · Received June 6, 2014

    Report

    Report Number
    2937457-2014-00991
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 9, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT'S PERITONEAL DIALYSIS NURSE REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2014. THE PATIENT WAS AT HOME, AND NOT CONNECTED TO THERAPY AT THE TIME OF PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331208 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LIBERTY TUBING| PD SOLUTION