BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3810628 · Received May 6, 2014

    Report

    Report Number
    2937457-2014-00766
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 16, 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 PHYSICIAN'S ASSESSMENT OF THE REPORTED INFORMATION AND THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED HE HAD DRAIN COMPLICATIONS. THE PT WAS HOSPITALIZED FOR HERNIA SURGERY. PT IS CURRENTLY OFF PD TREATMENT AND WILL NOT RESUME TREATMENT UNTIL (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271761 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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