BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 6063905 · Received October 28, 2016

    Report

    Report Number
    2937457-2016-01121
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    August 1, 2016
    Report Date
    December 12, 2016
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE DHR REVIEW CHECKLIST AND RELEASE PROCEDURE. A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S DAUGHTER STATED HER FATHER PASSED AWAY A FEW MONTHS AGO. FOLLOW-UP WAS MADE WITH THE PD PATIENT'S CLINIC REGISTERED NURSE (RN), WHO STATED THE PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2016 DUE TO GANGRENE ON THE PATIENT'S LEFT HEEL. PER PDRN THE PATIENT EXPIRED ON (B)(6) 2016, WHILE HOSPITALIZED DUE TO CARDIAC ARREST. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE PDRN STATED THE PATIENT HAD A KNOWN HISTORY OF HYPERTENSION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S DAUGHTER STATED HER FATHER PASSED AWAY A FEW MONTHS AGO. FOLLOW-UP WAS MADE WITH THE PD PATIENT'S CLINIC REGISTERED NURSE (RN), WHO STATED THE PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2016 DUE TO GANGRENE ON THE PATIENT¿S LEFT HEEL. PER PDRN THE PATIENT EXPIRED ON (B)(6) 2016, WHILE HOSPITALIZED DUE TO CARDIAC ARREST. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE PDRN STATED THE PATIENT HAD A KNOWN HISTORY OF HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715743 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| R DELFLEX PD SOLUTION| LIBERTY CYCLER CASSETTE