BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG CR3 CONTROLLER

    MDR report key: 7319887 · Received March 7, 2018

    Report

    Report Number
    3009763347-2017-00010
    Event Type
    Death
    Date Received
    March 7, 2018
    Date of Event
    September 8, 2017
    Report Date
    March 8, 2018
    Manufacturer
    ALUNG TECHNOLOGIES, INC
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE PATIENT DIED AFTER SUFFERING A CEREBRAL BLEED FOLLOWING HEMOLUNG THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451103 HEMOLUNG CR3 CONTROLLER HEMOLUNG CR4 CONTROLLER DQR ALUNG TECHNOLOGIES, INC HEMOLUNG CR3 CONTROLLER

    Patients

    Seq Age Sex Outcome Treatment
    1