BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4230593 · Received October 22, 2014

    Report

    Report Number
    2937457-2014-03023
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING. A SUPPLEMENT MEDWATCH REPORT WILL BE SUBMITTED WHEN MEDICAL RECORDS ARE RECEIVED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS ADMITTED DUE TO AN EPISODE OF PERITONITIS, WITHOUT ALLEGATION OF DEVICE MALFUNCTION. THE NURSE STATED THE SOURCE PERITONITIS WAS UNK. THE PT WAS ASSISTED BY A CAREGIVER TO COMPLETE PERITONEAL DIALYSIS TREATMENTS. THE PT WAS IN THE PROCESS OF SWITCHING TO HEMODIALYSIS THERAPY AND WAS BEING PLACED IN A LONG-TERM CARE FACILITY UPON HOSPITAL DISCHARGE. THE PT'S MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670785 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTION