BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM ONE WITH PUREFLOW SL

    MDR report key: 3820063 · Received May 15, 2014

    Report

    Report Number
    MW5036122
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 13, 2014
    Manufacturer
    NXSTAGE
    Product Code
    FKR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOME HEMODIALYSIS PATIENT RUNNING ON NXSTAGE MACHINE. DURING THE LAST 13 MINUTES OF THE TREATMENT, HUSBAND OF THE PATIENT HEARD A STRANGE NOISE AND FOUND THE PATIENT UNRESPONSIVE. CPR PERFORMED BUT UNABLE TO REVIVE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292089 SYSTEM ONE WITH PUREFLOW SL SYSTEM ONE WITH PUREFLOW SL FKR NXSTAGE
    292090 SYSTEM ONE WITH PUREFLOW SL SYSTEM ONE WITH PUREFLOW SL FKR NXSTAGE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death