BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 3817925 · Received May 1, 2014

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    Report

    Report Number
    2937457-2014-00737
    Event Type
    Death
    Date Received
    May 1, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS ADMITTED TO AN UNK HOSPITAL ON (B)(6) 2014, FOR AN UNK REASON. THE PT HAD A HISTORY OF CO-MORBIDITIES. ON (B)(6) 2014, THE PT DISCONTINUED DIALYSIS TREATMENTS AND PROCEEDED WITH COMFORT MEASURES ONLY (CMO). ON (B)(6) 2014, AT APPROXIMATELY 1300, THE PT EXPIRED. SINCE THE PT WENT CMO, HE WAS NOT BEING DIALYZED AT OR NEAR THE TIME OF HIS DEATH. THE PT'S WEIGHT AND DATE OF BIRTH ARE UNK. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THE LOT NUMBERS ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261946 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LIBERTY CYCLER CASSETTE