BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER, DUAL PATIENT CONNECT

    MDR report key: 3913427 · Received June 13, 2014

    Report

    Report Number
    8030665-2014-00472
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    February 22, 2014
    Report Date
    May 16, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION. THIS EVENT REPORT IS RELATED TO THREE SEPARATE PRODUCTS AND ASSOCIATED WITH MDR'S # 2937457-2014-01020 AND 8030665-2014-00472.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINIC THAT THE PATIENT EXPIRED DURING PD TREATMENT OR JUST AFTER. IT WAS REPORTED THAT PRIOR TO THE EVENT, THE PATIENT HAD BEEN HOSPITALIZED FOR CARDIOMYOPATHY, WAS TRANSFERRED TO A REHAB FACILITY AND WAS RELEASED ON (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349825 LIBERTY CYCLER, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death DELFLEX| LIBERTY CYCLER