BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3853035 · Received May 23, 2014

    Report

    Report Number
    8030665-2014-00446
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 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 FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL STAFF AND COMPLETION OF THE PLANT'S INVESTIGATION. THE RELATED MDRS #2937457-2014-00884, 8030665-2014-00446, AND 1713747-2014-99971.

    Description of Event or Problem · 1

    TUBING - 01. A PERITONEAL DIALYSIS PATIENT'S WIFE REPORTED THAT ON (B)(6) 2014 THE PATIENT WAS FEELING NAUSEOUS AND DEVELOPED A FEVER; HE WAS TAKEN TO THE HOSPITAL AND ADMITTED WITH PERITONITIS. HE WAS DISCHARGED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309116 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization