BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16164954 · Received January 13, 2023

    Report

    Report Number
    3009763347-2023-00005
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    May 8, 2020
    Report Date
    January 13, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004346
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER, WEIGHT, ETHNICITY, RACE: THIS PATIENT INFORMATION WAS NOT PROVIDED. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(4). MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. THROUGH REVIEW OF THE EXPANDED ACCESS FORM, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE SITE COORDINATOR HAD ALSO AT THE TIME OF OCCURRENCE NOTIFIED ALUNG OF THE DETERIORATION OF THE PATIENT. DESPITE ADEQUATE ANTICOAGULATION, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM, RIGHT HEART FAILURE, HYPOXEMIA WITH HEMODYNAMIC INSTABILITY, AND PNEUMOTHORAX REQUIRING CHEST TUBE. THE FAMILY INSTITUTED A DNR STATUS ON THE PATIENT, BUT AT THE TIME OF THE DETERIORATION OF THE PATIENT, THE HEMOLUNG WAS STILL PROVIDING ADEQUATE SUPPORT FOR THE PATIENT. THE DATA LOG FROM 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 CRITICAL ERRORS OCCURRED. THERAPY WAS PROVIDED AS INTENDED. PNEUMOTHORAX IS A KNOWN COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY. THERE IS NO INDICATION OF ANY RELATION TO HEMOLUNG THERAPY. EXAMINATION OF THE CONTROLLER DATA LOG SHOWS THAT THERAPY WAS PROVIDED AS INTENDED. ALUNG WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE VIEW OF ALL ALUNG 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 DURING HEMOLUNG EUA THERAPY A PATIENT EXPERIENCED PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. HEMOLUNG EUA THERAPY WAS NOT DISCONTINUED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132983 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19 QLN ALUNG TECHNOLOGIES, INC. HL-CR4-01-000 00850046004346

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Life Threatening| R