BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200032 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00060
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    June 1, 2020
    Report Date
    January 18, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    UDI-DI
    00850046004179
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(6). MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. DURING EMERGENCY USE HEMOLUNG THERAPY, IT WAS REPORTED THAT PATIENT EXPERIENCED BLEEDING AT CATHETER INSERTION SITE. ALUNG TECHNOLOGIES, INC. REPORTS THAT MEDICAL STAFF CALLED ASKING IF THEY COULD HOLD HEPARIN AND HOW LONG BEFORE THE CIRCUIT WOULD CLOT. ALUNG ADVISED THEM THAT THEY COULD HOLD THE HEPARIN AS PER THEIR STANDARD PRACTICE IN LIGHT OF BLEEDING. ALSO ADVISED A CERTAIN TIME PERIOD BEFORE THE CIRCUIT MIGHT CLOT IS UNPREDICTABLE. OFFERED TO CONTACT THE MEDICAL MONITOR IF THEY WOULD LIKE TO DISCUSS OPTIONS. THEY FELT COMFORTABLE HOLDING HEPARIN AND WOULD DISCUSS WITH PHYSICIAN. THE DATA LOG FROM HEMOLUNG 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. NO CRITICAL ERRORS OCCURRED. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING AT CATHETER INSERTION SITE A KNOWN POSSIBLE OCCURRENCE WITH EXTRACORPOREAL HEMOLUNG THERAPY. EXAMINATION OF THE CONTROLLER DATA LOG SHOWS 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 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. REPORTS THAT MEDICAL STAFF CALLED ASKING IF THEY COULD HOLD HEPARIN AND HOW LONG BEFORE THE CIRCUIT WOULD CLOT. ALUNG ADVISED THEM THAT THEY COULD HOLD THE HEPARIN AS PER THEIR STANDARD PRACTICE IN LIGHT OF BLEEDING. ALSO ADVISED A CERTAIN TIME PERIOD BEFORE THE CIRCUIT MIGHT CLOT IS UNPREDICTABLE. OFFERED TO CONTACT THE MEDICAL MONITOR IF THEY WOULD LIKE TO DISCUSS OPTIONS. THEY FELT COMFORTABLE HOLDING HEPARIN AND WOULD DISCUSS WITH PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406358 HEMOLUNG RAS CANNULA, CATHETER DQR ALUNG TECHNOLOGIES, INC. HL-CA10-00-000 00850046004179

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention| L