BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 3738643 · Received March 28, 2014

    Report

    Report Number
    2937457-2014-00512
    Event Type
    Death
    Date Received
    March 28, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE, NA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THE POST MARKET CLINICAL DEPARTMENT HAS REQUESTED PT MEDICAL RECORDS AND A PLANT INVESTIGATION WILL BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PHYSICIAN'S ASSESSMENT OF THE REPORTED INFO AND THE PLANT'S INVESTIGATION. RELATED MDR: 8030665-2014-00261 AND 1713747-2014-99923.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PT WAS FOUND DECEASED WHILE CONNECTED TO THE CYCLER. REF UF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186313 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE, NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PD CYCLER CASSETTE| UNK PD SOLUTION