BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG RAS

    MDR report key: 16179749 · Received January 16, 2023

    Report

    Report Number
    3009763347-2023-00014
    Event Type
    Death
    Date Received
    January 16, 2023
    Date of Event
    June 16, 2017
    Report Date
    January 16, 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

    LOT/SERIAL NUMBER WAS NOT PROVIDED, SO THE UDI AND EXPIRATION DATE COULD NOT BE DETERMINED. AS LOT NUMBER WAS NOT PROVIDED, MANUFACTURING DATE COULD NOT BE DETERMINED ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(6). ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT OF A PATIENT EXPERIENCING LOSS OF BLOOD FLOW TO THE BOWEL DURING THERAPY. MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS GIVEN AN ABDOMINAL CT THAT SHOWED THE ISCHEMIC BOWEL. THERAPY WAS ELECTIVELY CEASED. THE HEMOLUNG CATHETER WAS LOCKED WITH HEPARIN AND REMAINED IN PLACE. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE COLON AND POTENTIALLY RECTUM, STOMA FORMATION, AND CONTINUOUS RENAL REPLACEMENT THERAPY. THE PATIENT DIED, AND THIS OUTCOME WAS REPORTED AS UNRELATED TO THE USE OF THE HEMOLUNG DEVICE. AS NO FURTHER NOTIFICATION WAS RECEIVED REGARDING THIS ADVERSE EVENT, NO FURTHER INFORMATION IS AVAILABLE. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. ISCHEMIC BOWEL IS A KNOWN POTENTIAL COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY. 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 LOSS OF BLOOD FLOW TO THE BOWEL DURING HEMOLUNG THERAPY. MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS GIVEN AN ABDOMINAL CT THAT SHOWED THE ISCHEMIC BOWEL. THERAPY WAS ELECTIVELY CEASED. THE HEMOLUNG CATHETER WAS LOCKED WITH HEPARIN AND REMAINED IN PLACE. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE COLON AND POTENTIALLY RECTUM, STOMA FORMATION, AND CONTINUOUS RENAL REPLACEMENT THERAPY. THE PATIENT DIED, AND THIS OUTCOME WAS REPORTED AS UNRELATED TO THE USE OF THE HEMOLUNG DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135034 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| L| R