BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3980020 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01603
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 PERITONEAL DIALYSIS (PD) PT WAS HOSPITALIZED (DATE UNK) FOR A MINOR MYOCARDIAL INFARCTION AND WAS DISCHARGED ON (B)(6) 2014. PT REMAINED ON PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372192 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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