BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3812752 · Received May 2, 2014

    Report

    Report Number
    2937457-2014-00743
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PT WAS HOSPITALIZED FOR A COUPLE OF DAYS FOR LOW BLOOD SUGAR. SHE STATED THIS WAS NOT CYCLER RELATED. MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265333 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DELFLEX SOLUTIONS| LIBERTY CYCLER CASSETTE