BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200015 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00048
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    July 23, 2019
    Report Date
    January 18, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QOH
    UDI-DI
    00850046004346
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ALBANY, NEW YORK. MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. ALUNG TECHNOLOGIES, INC. RECEIEVED A REPORT OF A PATIENT EXPERIENCING THROMBOCYTOPENIA DURING HEMOLUNG THERAPY. A BLOOD TRANSFUSION WAS REQUIRED. THE DATA LOG FROM HEMOLUNG THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. DURING HEMOLUNG THERAPY, A 102 ERROR OCCURRED IN WHICH THE O2 SENSOR VALUE WAS GREATER THAN 24%. THE CONTROLLER SOFTWARE OPERATED AS INTENDED BY STOPPING THE PUMP. TECHNICAL SUPPORT WAS PROVIDED TO THE CLINICAL STAFF IN WHICH THEY POWER CYCLED DEVICE AND CHOSE TO CONTINUE THE HEMOLUNG THERAPY AT THEIR DISCRETION. NO ABNORMALITIES WERE NOTED WITHIN THE CO2 REMOVAL AND BLOOD FLOW GRAPHS. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CAPA WAS OPENED BECAUSE OF THIS EVENY. THROMBOCYTOPENIA IS A KNOWN POSSIBLE OCCURRENCE WITH EXTRACORPOREAL HEMOLUNG THERAPY. REVIEW OF THE CONTROLLER DATA LOG SHOWS 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 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. A BLOOD TRANSFUSION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405356 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 Life Threatening| R