BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG CATHETER KIT

    MDR report key: 6602679 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00003
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    May 13, 2015
    Report Date
    May 31, 2017
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS AN EXPORTER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING PROVIDED AS A RESULT OF FDA 483 FILE NUMBER 3009763347 OBSERVATION 1. THE DETAILS OF THE PATIENT CONDITION ARE: PER (B)(6) THE PATIENT EXPERIENCED BOWEL ISCHEMIA WITH UNKNOWN RELATION TO HEMOLUNG THERAPY. AWAITING FURTHER INFORMATION. UPDATE: THE TREATING PHYSICIAN FEELS THE LIKELIHOOD OF THE HEMOLUNG TRANSFERRING AN AIR EMBOLUS OR BLOOD CLOT DIRECTLY TO THE BOWEL IS VERY LOW. AN ECHO SHOWED NO PATENT FORMAN OVALE. THE CARTRIDGE AND CATHETER WERE EXAMINED POST USE BY THE PHYSICIAN AND PAUL TURNER ANS APPEARED REMARKABLE CLEAN WITH NO EVIDENCE OF CLOTTING. THE PATIENT DID DIE OF MULTI-ORGAN FAILURE POST-HEMOLUNG USE. TGA WAS NOTIFIED AND THE FINAL CLOSURE REPORT FROM TGA WAS RECEIVED BY ALUNG. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383864 HEMOLUNG CATHETER KIT HEMOLUNG CATHETER KIT DQR ALUNG TECHNOLOGIES, INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death