BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16189451 · Received January 17, 2023

    Report

    Report Number
    3009763347-2023-00035
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 10, 2020
    Report Date
    January 17, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 FORM, IT WAS REPORTED THAT THE PATIENT EXPERIENCED MINOR BLEEDING AT CATHETER INSERTION SITE. THE EVENT RESOLVED ITSELF AND NO BLOOD PRODUCTS WERE GIVEN IN RESPONSE. THERAPY WAS NOT DISCONTINUED AS A RESULT OF THIS ISSUE. 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. THERAPY WAS PROVIDED AS INTENDED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING IS A KNOWN POSSIBLE COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY. THE TREATING PHYSICIAN WAS ABLE TO FULLY REALIZE THEIR CLINICAL GOALS AND ADEQUATE BENEFIT OF THERAPY WAS REALIZED. 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 EUA HEMOLUNG THERAPY. HEMOLUNG THERAPY WAS NOT DISCONTINUED AS A RESULT OF THIS EVENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16253 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19 QLN ALUNG TECHNOLOGIES, INC. HL-CR4-01-000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other