BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200036 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00063
    Event Type
    Injury
    Date Received
    January 18, 2023
    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
    OH, 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 CLEVELAND, OHIO. MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. THROUGH REVIEW OF THE EXPANDED ACCESS FORM, ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT THAT A PATIENT EXPERIENCED A MAJOR BLEED IN THE ORAL CAVITY THAT RESULTED IN THE NEED FOR 3 UNITS OF BLOOD. THE SOURCE OF BLEED NOTED AS BEING DUE TO SUCTION TRAUMA. 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 CRITICAL ERRORS OCCURRED. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH USE OF EXTRACORPOREAL HEMOLUNG THERAPY AND THE USE OF ANTICOAGULATION. 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. RECEIVED A REPORT THAT A PATIENT EXPERIENCED A MAJOR BLEED IN THE ORAL CAVITY DURING HEMOLUNG THERAPY THAT RESULTED IN THE NEED FOR 3 UNITS OF BLOOD. THE SOURCE OF BLEED NOTED AS BEING DUE TO SUCTION TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362758 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC. HL-CR4-01-000 PART NUMBER 00850046004346

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention| L