BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3820769 · Received May 8, 2014

    Report

    Report Number
    2937457-2014-00792
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ATTEMPTS TO THE PATIENTS' NURSE HAVE BEEN MADE WITH NO ADDITIONAL INFORMATION PROVIDED. THIS MDR INCLUDES ALL EVENT INFORMATION RECEIVED TO DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENTS' NURSE CALLED TECH SUPPORT WITH A QUESTION: DURING THIS CALL IT WAS DISCOVERED THAT THE PATIENT WAS IN THE HOSPITAL. THE PATIENT WAS IN THE HOSPITAL BEING TREATED FOR C-DIFF. THE PATIENT HAS SINCE BEEN DISCHARGED, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279140 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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