BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLUNG RAS

    MDR report key: 16179754 · Received January 16, 2023

    Report

    Report Number
    3009763347-2023-00016
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    July 6, 2017
    Report Date
    January 16, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    PMA / PMN Number
    DEN210006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN STOKE ON TRENT, UNITED KINGDOM. THROUGH REVIEW OF THE FINAL CLINICAL STUDY ADVERSE EVENT LISTINGS, IT WAS REPORTED THAT A DEVICE MALFUNCTION OCCURRED DURING THERAPY. THROUGHOUT PATIENT THERAPY, THERE WERE CONCERNS REGARDING CO2 REMOVAL. AS PER THE EVENT, MULTIPLE LOW CO2 REMOVAL ALARMS OCCURRED. AS NO FURTHER NOTIFICATION WAS RECEIVED REGARDING THIS ADVERSE EVENT, NO FURTHER INFORMATION IS AVAILABLE. THERE ARE MANY FACTORS THAT CAN IMPACT LEVEL OF CO2 REMOVAL DURING THERAPY. THIS IS A KNOWN POTENTIAL COMPLICATION. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. FROM THE EVENT, CLINICAL SUPPORT WAS PROVIDED WITHOUT ISSUE IN RESPONSE TO THE CONCERNS. 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 DEVICE MALFUNCTION DURING HEMOLUNG THERAPY. DURING THERAPY THERE WERE CONCERNS REGARDING CO2 REMOVAL. MULTIPLE LOW CO2 REMOVAL ALARMS OCCURRED. THE MALFUNCTION RESULTED IN UNELECTIVE THERAPY CESSATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135039 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male