BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG RAS

    MDR report key: 16211882 · Received January 19, 2023

    Report

    Report Number
    3009763347-2023-00084
    Event Type
    Death
    Date Received
    January 19, 2023
    Date of Event
    July 12, 2016
    Report Date
    January 19, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(6). MEDICAL INTERVENTION WAS USED IN AN ATTEMPT TO AVOID FURTHER PATIENT INJURY BUT THE END RESULT WAS DEATH THAT WAS UNLIKELY TO BE RELATED TO THE USE OF THE HEMOLUNG DEVICE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCK SECONDARY TO SEPSIS AND CARDIOGENIC. . THREE HOURS AFTER START OF THERAPY, PATIENT BEGAN TO DETERIORATE (DECREASING BLOOD PRESSURE). INOTROPIC SUPPORT INCREASED OVER NEXT TEN HOURS (TO MAXIMUM). LIKELY CAUSE ACCORDING TO CLINICAL TEAM IS SEPSIS AND POSSIBLY CARDIOGENIC SHOCK. DUE TO REFRACTORY HYPOTENSION CLINICAL TEAM MADE PATIENT DNR, BUT ORGAN SUPPORT CONTINUED. 22 HOURS AFTER RANDOMIZATION, PATIENT ARRESTED AND DEATH OCCURRED. THIS EVENT LED TO PATIENT DEATH BUT WAS UNLIKELY TO BE RELATED TO USE OF THE DEVICE. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. SHOCK IS A KNOWN POTENTIAL COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY AND IN GENERAL CRITICALLY ILL PATIENTS.. ALUNG TECHNOLOGIES, INC. WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE VIEW OF ALL ALUNG TECHNOLOGIES, INC. COMPLAINTS, WHICH IDENTIFIED THAT THE REPORTING DECISION FOR THIS COMPLAINT WAS NOT CORRECT. THIS MDR IS BEING FILED RETROSPECTIVELY TO CORRECT THE ERROR IN THE REPORTING DECISION.

    Description of Event or Problem · 0

    ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT OF A PATIENT EXPERIENCING SHOCK SECONDARY TO SEPSIS THREE HOURS INTO HEMOLUNG THERAPY. THIS WAS INDICATED BY THE PATIENT BEGINNING TO DETERIORATE (FALLING BLOOD PRESSURE). THE CLINICAL TEAM RELAYED TO ALUNG TECHNOLOGIES, INC. THAT THIS WAS POSSIBLY CARDIOGENIC SHOCK. INOTROPIC SUPPORT INCREASED OVER THE NEXT TEN HOURS TO THE MAXIMUM AMOUNT. DUE TO REFRACTORY HYPOTENSION THE CLINICAL TEAM MADE THE PATIENT DNAR BUT ORGAN SUPPORT CONTINUED. 22 HOURS AFTER THE COMMENCEMENT OF THE STUDY THE PATIENT ARRESTED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165578 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC. HL-CR3-01-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| D| R