BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4172585 · Received October 8, 2014

    Report

    Report Number
    2937457-2014-02858
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 25, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS ADMITTED ON (B)(6) 2014 DUE TO FLUID OVERLOAD AND HYPERTENSION. THERE WAS NO REPORTABLE DEVICE MALFUNCTION, NO ISSUE PERTAINING TO INFECTION OR ISSUES WITH THE CATHETER. THE NURSE STATED THE PT CONTINUED CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WHILE IN THE HOSPITAL, THUS NO TREATMENTS WERE MISSED. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014, AND THE PT'S SIGNS AND SYMPTOMS OF FLUID VOLUME OVERLOAD RESOLVED. AS OF (B)(6) 2014 THE PT CONTINUED TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633368 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R