BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4137967 · Received September 29, 2014

    Report

    Report Number
    2937457-2014-02802
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    August 30, 2014
    Report Date
    August 30, 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.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT'S CARETAKER REPORTED THE PT WAS HOSPITALIZED FOR PERITONITIS AND THAT THE PT'S INFECTION WAS DUE TO IMPROPER TECHNIQUE AND NON-COMPLIANCE. THE CARETAKER STATED THE PT HAD BEEN IN THE HOSPITAL FOR THREE DAYS. THE MACHINE SERIAL NUMBER IN USE COULD NOT BE CONFIRMED. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604706 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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