BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16179787 · Received January 16, 2023

    Report

    Report Number
    3009763347-2023-00026
    Event Type
    Injury
    Date Received
    January 16, 2023
    Date of Event
    March 30, 2017
    Report Date
    January 16, 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

    LOT/SERIAL NUMBER WAS NOT PROVIDED, SO THE UDI AND EXPIRATION DATE COULD NOT BE DETERMINED. AS LOT NUMBER WAS NOT PROVIDED, MANUFACTURING DATE COULD NOT BE DETERMINED. 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 HEMATURIA. AS NO FURTHER NOTIFICATION WAS RECEIVED REGARDING THIS ADVERSE EVENT, NO FURTHER INFORMATION IS AVAILABLE. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING AND HEMATURIA ARE KNOWN POTENTIAL COMPLICATIONS 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 BLOOD IN THE URINE 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
    751500 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other