BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16211889 · Received January 19, 2023

    Report

    Report Number
    3009763347-2023-00085
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    May 4, 2018
    Report Date
    January 19, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). THROUGH REVIEW OF THE FINAL CLINICAL STUDY ADVERSE EVENT LISTINGS, IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTHERMIA. AS NO FURTHER NOTIFICATION WAS RECEIVED REGARDING THIS ADVERSE EVENT, NO FURTHER INFORMATION IS AVAILABLE. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. HYPOTHERMIA IS A KNOWN POTENTIAL COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY. 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 OF A PATIENT EXPERIENCING HYPOTHERMIA DURING HEMOLUNG THERAPY. THERAPY WAS STILL PROVIDED AS INTENDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165585 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC. HL-CR3-00-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other