BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16163805 · Received January 13, 2023

    Report

    Report Number
    3009763347-2023-00006
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    October 23, 2021
    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

    ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(4), FLORIDA. WITHIN THE EXPANDED ACCESS DATA COLLECTION FORM, IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED BLEEDING FROM LEFT CHEST TUBE, WHICH RESULTED IN PATIENT BEING DISCONTINUED FROM HEPARIN. ALTHOUGH HYPERCAPNIA WAS RELATIVELY CONTROLLED WITH VENTILATORY SUPPORT, THE PATIENT COULD NOT TOLERATE ANTICOAGULATION AND HAD BLEEDING LOSS WHICH REQUIRED A TOTAL OF 7 UNITS OF BLOOD. IT WAS DOCUMENTED THAT BLOOD FLOW HAD DECREASED AND CLOTTING WAS SUSPECTED. THERAPY WAS DISCONTINUED AS A RESULT. THIS IS NOT UNEXPECTED WITH DISCONTINUATION OF ANTICOAGULATION. TO CORRECT THE PATIENT'S COAGULOPATHY, PATIENT RECEIVED 2 UNITS OF CRYOPRECIPITATE AND AMINOCAPROIC ACID. FOLLOWING THERAPY, THE DATA LOG FROM THERAPY WAS RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. REVIEW OF THE DATA SHOWS CONSISTENT CO2 REMOVAL AND BLOOD FLOW THROUGHOUT THERAPY. NO ABNORMAL USER INTERACTION. THERAPY RAN AS INTENDED. THERE WERE NO UNEXPECTED ALARMS AND NO CRITICAL ERRORS. THE SOFTWARE OPERATED AS INTENDED. BLEEDING IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH USE OF ANTICOAGULATION IN THERAPY. THE DATA LOG WAS REVIEWED AND SHOWED 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 OF A PATIENT EXPERIENCING BLEEDING FROM THE LEFT CHEST TUBE AND BEING COAGULOPATHIC DURING HEMOLUNG RAS EUA THERAPY. SEVEN UNITS OF BLOOD WERE ADMINISTERED, 2 UNITS OF CRYOPREIPITATE AND AMINOCAPRIC ACID. HEMOLUNG THERAPY WAS NON-ELECTIVELY DISCONTINUED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963941 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 53 YR Male Required Intervention| L