BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16444840 · Received February 27, 2023

    Report

    Report Number
    3009763347-2023-00117
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    January 29, 2022
    Report Date
    February 27, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    UDI-DI
    00850046004179
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. DEVICE MANUFACTURED IN MAY 2021. EXACT DATE IS NOT DOCUMENTED, AS THE VARIOUS COMPONENTS OF THE KIT ARE MANUFACTURED ON DIFFERENT DAYS BEFORE ASSEMBLING INTO THE KIT. AS SUCH, MAY 31, 2021 WAS CHOSEN FOR THIS FIELD. NOTE: DEVICES ARE NOT STERILIZED IMMEDIATELY SO THE EXPIRATION DATE IS NOT BASED ON THE MANUFACTURE DATE BUT RATHER ON THE DATE OF STERILIZATION, WHICH WAS JULY 19, 2021 IN THIS CASE (EXPIRATION DATE 2 YEARS LATER, IN JULY 2023). ADDITIONALLY, THIS IS AN OLDER DEVICE AND THE PROCESS FOR DOCUMENTING MANUFACTURE DATES HAS CHANGED, SO NEWER PRODUCTS ALL HAVE AN EXACT MANUFACTURE DATE. ALUNG TECHNOLOGIES MANUFACTURES THE HEMOLUNG 15.5FR JUGULAR CATHETER. THIS INCIDENT OCCURRED IN LEXINGTON, KENTUCKY. MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. THERE IS NO ALLEGED DEVICE MALFUNCTION WHICH OCCURRED IN RELATION TO THE REPORTED PATIENT ADVERSE EVENT. THE DATA LOG FROM HEMOLUNG THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. THE DATA LOG SHOWED CONSISTENT BLOOD FLOWS AND CO2 REMOVAL THROUGHOUT THERAPY, AND CO2 REMOVAL AND BLOOD FLOW GRAPHS SHOW THAT HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CORRECTIVE ACTION WAS INITIATED FOR THIS EVENT. BLEEDING AT THE CATHETER SITE IS A KNOWN POTENTIAL COMPLICATION WHICH CAN OCCUR DURING EXTRACORPOREAL HEMOLUNG THERAPY. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE REVIEW 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. DEVICE DISCARDED.

    Description of Event or Problem · 0

    ALUNG TECHNOLOGIES, INC. WAS MADE AWARE OF A PATIENT WHO EXPERIENCED SEVERE CATHETER SITE BLEEDING DURING SUPPORT UTILIZING A HEMOLUNG 15.5FR JUGULAR CATHETER. THE BLEEDING WAS MANAGED BY PLACING A SUTURE AT THE INSERTION SITE AND APPLYING A PRESSURE DRESSING. A TRANSFUSION OF ONE UNIT OF RED BLOOD CELLS WAS REQUIRED. THERAPY WAS STILL PROVIDED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787283 HEMOLUNG RAS CANNULA, CATHETER DQR ALUNG TECHNOLOGIES, INC. 40900 00850046004179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention