BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16435622 · Received February 24, 2023

    Report

    Report Number
    3009763347-2023-00115
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    March 4, 2022
    Report Date
    February 24, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    UDI-DI
    00850046004056
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE INCIDENT OCCURRED IN MINNEAPOLIS, MINNESOTA. MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. THE DATA LOG FROM HEMOLUNG THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. CONSISTENT BLOOD FLOWS AND CO2 REMOVAL WERE OBSERVED AT THE TIME OF THE EVENT. THE DATE LOG SHOWED THAT TWO DAYS FOLLOWING THE EVENT, THE PATIENT WAS RE-CANNULATED AND A NEW CIRCUIT WAS CONNECTED WITHOUT ISSUE. THERE WERE NO ABNORMAL USER INTERACTIONS IDENTIFIED IN THE DATA LOG ON THE REPORTED EVENT DATE. THERAPY WAS PROVIDED AS INTENDED. NO CORRECTIVE ACTION WAS IDENTIFIED FOR THIS EVENT. ANEMIA IS A KNOWN POSSIBLE OCCURRENCE WITH EXTRACORPOREAL HEMOLUNG THERAPY. REVIEW OF 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 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. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DATA LOG REVIEWED.

    Description of Event or Problem · 0

    ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT THAT A PATIENT EXPERIENCED SEVERE AND ACUTE ANEMIA DURING SUPPORT UTILIZING A HEMOLUNG RAS CONTROLLER. THE ANEMIA WAS MANAGED THROUGH ADMINISTERING FOUR UNITS OF PRBCS DURING A 24-HOUR PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023760 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC. 21000 00850046004056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention