BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200026 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00057
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    April 17, 2020
    Report Date
    January 18, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    UDI-DI
    00850046004346
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 LOUISVILLE, KENTUCKY. MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. DURING EMERGENCY USE HEMOLUNG THERAPY, THE PATIENT EXPERIENCED HEMORRHAGOC SHOCK. SITE STAFF NOTIFIED ALUNG TECHNOLOGIES, INC. OF A LOW BLOOD FLOW ALARM OCCURRING ON THE CONTROLLER. AFTER TWO HOURS OF HEMOLUNG THERAPY, THE PATIENT STARTED TO HAVE MASSIVE BLEEDING FROM THE RIGHT FEMORAL ARTERY. THE LOW BLOOD FLOW WAS LIKELY RELATED TO HYPOTENSION AND THE EXPANDING RIGHT GROIN HEMATOMA. ECHO CONFIRMED ARTERIAL INJURY IN RIGHT GROIN. THE PATIENT WAS TREATED WITH PHARMACOLOGICAL SUPPORT, MULTIPLE BLOOD PRODUCTS, AND THE MAX SETTINGS ON THE HEMOLUNG. ONCE STABILIZED, THE PATIENT WAS TRANSPORTED TO THE OR FOR ARTERIAL REPAIR. POST REPAIR, THE BLOOD FLOW STABILIZED AND THE ALARM CEASED. THUS, THE CONTROLLER OPERATED AS INTENDED DURING THE ALARM. ALUNG TECHNOLOGIES, INC. WAS NOTIFIED THAT DURING THE ARTERIAL REPAIR IN THE OR, THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK IN WHICH THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND CODED. THE PATIENT WAS STABILIZED, THE PROCEDURE COMPLETED, AND THE PATIENT WAS THEN TRANSFERRED. THE DATA LOG FROM HEMOLUNG THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. NO ABNORMALITIES WERE NOTED WITHIN THE CO2 REMOVAL AND BLOOD FLOW GRAPHS. NO UNEXPECTED ALARMS OR ERRORS OCCURRED. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING, ARTERIAL INJURY, AND HEMORRHAGIC SHOCK ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE CATHETER PROCESS. EXAMINATION OF THE CONTROLLER DATA LOG SHOWS THAT HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. 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. RECEIEVED A REPORT THAT A PATIENT EXPERIENCED HEMORRHAGIC SHOCK DURING EMERGENCY USE HEMOLUNG THERAPY. MEDICATION WAS GIVEN AND A BLOOD TRANSFUSION OCCURED. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND CODED DURING VASCULAR REPAIR IN OR. THE PATIENT WAS STABILIZED AND THE PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406353 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC. HL-CR4-01-000 00850046004346

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention| L