BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 6000070 · Received October 5, 2016

    Report

    Report Number
    2937457-2016-01074
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 4, 2016
    Report Date
    October 28, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE PLANT'S EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A FOLLOW UP CALL TO THE PATIENT'S CLINIC FOR AN UNRELATED EVENT THAT THE PATIENT EXPIRED ON (B)(6) 2016 WITH THE CAUSE OF DEATH REPORTED TO BE CARDIAC ARREST WITH SECONDARY COMPLICATIONS FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). DOCUMENTATION RELATING TO THE PATIENT'S DEATH WAS REQUESTED FROM THE PATIENT'S PERITONEAL DIALYSIS NURSE, BUT HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652169 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death LIBERTY CYCLER CASSETTE| PD FLUID