BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIERTY CYCLER

    MDR report key: 3820158 · Received May 9, 2014

    Report

    Report Number
    2937457-2014-00799
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PHYSICIAN'S ASSESSMENT OF THE REPORTED INFORMATION AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE CALLED IN FOR INFORMATION ON USING THE CYCLER, AS PATIENT WAS HOSPITALIZED FOR FAILURE TO THRIVE. THE PATIENT STOPPED EATING AND DRINKING OR 10 DAYS AND WAS SUBSEQUENTLY TRANSFERRED TO HOSPICE AND DIED ON (B)(6) 2014 FROM A HEART ATTACK. NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281291 LIERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H LIBERTY CYCLER CASSETTE| DELFLEX SOLUTIONS