BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16211848 · Received January 19, 2023

    Report

    Report Number
    3009763347-2023-00083
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    January 11, 2021
    Report Date
    January 19, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004346
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SEGUIN, TEXAS. MEDICAL INTERVENTION WAS NECESSARY TO AVOID FURTHER PATIENT INJURY. IT WAS REPORTED THAT DURING EUA THERAPY THE PATIENT EXPERIENCED RECTAL BLEEDING AND ELEVATED APTT. THE PATIENT EXPERIENCED SUSTAINED HYPOTENSIVE AND HYPOXIC STATE AFTER PASSING BLOOD CLOT IN STOOL. HEMOLUNG SETTINGS, PRESSORS AND VENTILATORY SUPPORT MAXED OUT. HEPARIN HELD AND SURGICAL INTERVENTION COMPRISED OF ENDOCLIP APPLICATION TO ULCER WITH DIVERTICULITIS NOTED. THERAPY CONTINUED AS PLANNED WITH HEPARIN INFUSION RESUMING AFTER STABILIZATION AND PRONATION OF PATIENT. AS PER THE TREATING PHYSICIAN, THE DEVICE WORKED GREAT AT LOWERING PCO2, BUT IT WAS STARTED TOO LATE IN THE COURSE OF THE PATIENT'S DISEASE. 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. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING IS A KNOWN POTENTIAL COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY. EXAMINATION OF THE CONTROLLER DATA LOG SHOWS THAT 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 OF A PATIENT EXPERIENCING RECTAL BLEEDING DURING EUA HEMOLUNG THERAPY. SURGICAL INTERVENTION WAS REQUIRED TO APPLY AN ENDOCLIP TO ULCER. DIVERTICULITIS WAS NOTED. BLOOD THINNERS WERE RESUMED AFTER PATIENT STABILIZED AND THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394003 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 Female Life Threatening| R