BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16163683 · Received January 13, 2023

    Report

    Report Number
    3009763347-2023-00002
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    September 28, 2021
    Report Date
    January 13, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004162
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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)(6). THROUGH REVIEW OF THE EXPANDED ACCESS DATA COLLECTION FORM, IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AT CATHETER INSERTION SITE. BLEEDING INCREASED OVERNIGHT AND SURGISEAL WAS PLACED. THERAPY WAS NOT DISCONTINUED AS A RESULT OF THIS ISSUE. SIGNIFICANT BLEEDING OCCURRED AT CANNULA DISCONTINUATION. THERE WAS NO REPORTED INDICATION THIS WAS RELATED TO THERAPY. FOLLOWING THERAPY THE DATA LOG WAS RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. CLINICAL DATA REVIEW SHOWS CONSISTENT BLOOD FLOWS AND CO2 REMOVAL THROUGHOUT THERAPY. NO ABNORMAL USER INTERACTIONS NOTED. THERE WERE NO UNEXPECTED ALARMS AND NO CRITICAL ERRORS. THE SOFTWARE OPERATED AS INTENDED. BLEEDING IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH USE OF EXTRACORPOREAL THERAPY. BLEEDING AT INSERTION SITE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH USE OF CATHETERS. DATA LOG REVIEW SHOWS THERAPY WAS PROVIDED AS INTENDED. THERE WAS NO INDICATION THAT THE COMPLICATION WAS RELATED TO USE OF THE DEVICE. 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 AT THE CATHETER SITE DURING HEMOLUNG RAS EUA THERAPY. MEDICAL INTERVENTION WAS REQUIRED BY APPLYING SURGISEAL. HEMOLUNG THERAPY WAS NOT DISCONTINUED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134031 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19 QLN ALUNG TECHNOLOGIES, INC. HL-CA09-00-000 00850046004162

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Life Threatening| R