BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16189488 · Received January 17, 2023

    Report

    Report Number
    3009763347-2023-00039
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    January 25, 2020
    Report Date
    January 17, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    UDI-DI
    00850046004179
    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

    PATIENT INFORMATION WAS NOT PROVIDED. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(6). MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. AN EVENT WAS REPORTED IN WHICH THE SUBJECT EXPERIENCED ACUTE BLOOD LOSS. OOZING AT CATHETER SITE, DESPITE ATTEMPTS TO CONTROL WITH SURGICAL GAUZE. AN ADDITIONAL SUTURE WAS PLACED AND OOZING RESOLVED. THE DATA LOG FROM HEMOLUNG THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. APPROXIMATELY ONE HOUR INTO HEMOLUNG THERAPY, THE CONTROLLER BEGAN ALARMING THAT AIR WAS IN THE BLOOD LINE. AFTER CAREFUL OBSERVATION, IT WAS DETERMINED THAT THERE WAS NO AIR IN THE BLOOD LINE. SITE STAFF SUCCESSFULLY SWITCHED HEMOLUNG THERAPY TO A BACKUP CONTROLLER WITHOUT ISSUE. THE DATA LOG FOR THE REMAINDER OF THE HEMOLUNG THERAPY SHOW THAT CO2 REMOVAL AND BLOOD FLOW GRAPHS WERE AS EXPECTED. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. THE RETURNED DEVICE WAS EVALUATED FOR ANY ABNORMALITIES. THERE WERE NO FINDINGS WITHIN THE ANALYSIS. THERE WERE NO MECHANICAL INDICATIONS THAT THE DEVICE WOULD HAVE MALFUNCTIONED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. ACUTE BLOOD LOSS WITH BLEEDING AT THE CATHETER SITE IS A KNOWN POSSIBLE OCCURRENCE WITH HEMOLUNG THERAPY. EXAMINATION OF THE RETURNED DISPOSABLES AS WELL AS THE CONTROLLER DATA LOG SHOW THAT HEMOLUNG 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 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 BLEEDING WAS NOTED AT THE CATHETER SITE OF THE HEMOLUNG CATHETER DURING A PROCEDURE AND CONTINUED DESPITE ATTEMPTS TO CONTROL WITH SURGICAL GAUZE. AN ADDITIONAL SUTURE WAS PLACED AND BLEEDING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3110 HEMOLUNG RAS CANNULA, CATHETER DQR ALUNG TECHNOLOGIES, INC. HL-CA10-00-000 00850046004179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R