BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16211937 · Received January 19, 2023

    Report

    Report Number
    3009763347-2023-00093
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    March 7, 2021
    Report Date
    January 19, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    UDI-DI
    00850046004346
    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. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN LOUISVILLE, KENTUCKY. ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT OF A PATIENT EXPERIENCING THROMBOCYTOPENIA DURING THERAPY. THERAPY WAS PROVIDED AS INTENDED. MEDICAL INTERVENTION WAS REQUIRED BY CHANGING THE MEDICATION ADMINISTERED FROM HEPARIN TO ARGATROBAN. THE DATA LOG WAS RECEIVED AND REVIEWED BY CLINICAL AND SOFTWARE ENGINEERING STAFF. THE CO2 REMOVAL AND BLOOD FLOW GRAPHS SHOW THAT THERAPY WAS PROVIDED AS INTENDED. AS INDICATED WITHIN THIS CASE, THERAPY WAS ENDED DUE TO A PROBABLE CIRCUIT OCCLUSION. PATIENT THERAPY WAS ALREADY PLANNED TO END. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. THROMBOCYTOPENIA IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH USE OF EXTRACORPOREAL THERAPY. REVIEW OF THE DATA LOG SHOWS THAT 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 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 THROMBOCYTOPENIA DURING HEMOLUNG THERAPY. THERAPY WAS PROVIDED AS INTENDED. MEDICAL INTERVENTION WAS REQUIRED BY CHANGING THE MEDICATION ADMINISTERED FROM HEPARIN TO ARGATROBAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155924 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL QOH ALUNG TECHNOLOGIES, INC. HL-CR4-01-000 00850046004346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L