BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16211976 · Received January 19, 2023

    Report

    Report Number
    3009763347-2023-00108
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    December 7, 2020
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PATIENT INFORMATION WAS NOT PROVIDED. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN PHILADELPHIA, PENNSYLVANIA . THROUGH REVIEW OF THE EXPANDED ACCESS FORM, IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEAD BLEED THE DAY AFTER STARTING THERAPY. PATIENT WAS NOT RECEIVING ANTICOAGULATION PRIOR TO HEMOLUNG, EVEN THOUGH THE PATIENT WAS ON ECMO DUE TO CHEST TUBE BLEEDING. HEMOLUNG THERAPY CONTINUED. AS PER THE TREATING PHYSICIAN, THE HEMOLUNG ACHIEVED GOAL OVER FIRST 22 HOURS. 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 DUE TO HEPARIN/ANTICOAGULATION. 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 THAT A PATIENT EXPERIENCED A HEAD BLEED DURING EUA HEMOLUNG THERAPY. HEPARIN WAS STOPPED, BUT HEMOLUNG THERAPY CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406011 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 40 YR Male Required Intervention| L