BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 5999617 · Received October 5, 2016

    Report

    Report Number
    2937457-2016-01070
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 11, 2016
    Report Date
    October 31, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    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 PLANT'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A RETURN PRODUCT INVESTIGATION WAS NOT PERFORMED AS THE CYCLER WAS NOT REPLACED IN THE COMPLAINT FOR THE REPORTED SYMPTOMS. FIELD SERVICE INVESTIGATION IS NOT PERFORMED ON CYCLERS. 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 RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    CLINICAL REVIEW WAS PERFORMED FOR ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER, INCLUDING THE REPORTED PAST MEDICAL HISTORY, PAST SURGICAL HISTORY, AND CONCOMITANT MEDICATIONS. THERE WAS NO INFORMATION SUPPORTING A POSSIBLE ASSOCIATION BETWEEN THE FRESENIUS DIALYSIS PRODUCTS, THE EVENT OF OSTEOMYELITIS, AND THE OUTCOMES OF HOSPITALIZATION AND DEATH.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT'S DAUGHTER REPORTED THAT HER FATHER HAD DIED DURING AN UNRELATED MATTER. DURING FOLLOW-UP WITH THE PATIENT'S NURSE IT WAS REPORTED THAT THE PATIENT DIED WHILE IN THE HOSPITAL AND NO FURTHER INFORMATION WAS AVAILABLE. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    THE PATIENT WAS TRANSFERRED FROM THEIR LONG TERM CARE FACILITY DUE TO THE OSTEOMYELITIS. THE CAUSE OF DEATH WAS NOT KNOWN. MEDICAL RECORDS WERE REQUESTED AND WILL NOT BE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651785 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death DELFLEX PD SOLUTIONS