BEUDAMED
    FDA Adverse Event Injury Summary report: N

    \HEMOLUNG RAS

    MDR report key: 16163723 · Received January 13, 2023

    Report

    Report Number
    3009763347-2023-00007
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    July 25, 2021
    Report Date
    January 13, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004346
    PMA / PMN Number
    DEN210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 (B)(4), TEXAS. AS PER THE EXPANDED ACCESS DATA COLLECTION FORM: AFTER HEMOLUNG CATHETER PLACEMENT AND INITIATION OF REQUIRED HEPARIN DRIP, THE PATIENT'S HEMOGLOBIN LEVEL PROGRESSIVELY WORSENED AND DECREASED FROM 14 G/DL TO 10 G/DL AND THE PATIENT DEVELOPED A RAPIDLY PROGRESSING HEMATOMA AROUND THE CATHETER INSERTION POINT. NO TRANSFUSION WAS REQUIRED. THE PHYSICIAN NOTED THE PATIENT EXPERIENCED AN EXPANDING HEMATOMA AROUND THE CATHETER SITE. HEMOLUNG THERAPY WAS STOPPED. HEPARIN WAS STOPPED AND PROTAMINE SULFATE WAS GIVEN. THE HEMATOMA STABILIZED. THE PHYSICIAN ALSO REPORTED THAT THEY WERE VERY SATISFIED WITH THE USE OF THE HEMOLUNG IN THIS CASE AND SIGNIFICANT BENEFIT WAS REALIZED. THE DATA LOG WAS COLLECTED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. REVIEW OF THE LOGS SHOWED CONSISTENT BLOOD FLOWS AND CO2 REMOVAL THROUGHOUT THERAPY. NO UNEXPECTED ALARMS OCCURRED. THERAPY WAS PROVIDED AS INTENDED. ANEMIA IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH EXTRACORPOREAL THERAPY AND/OR CRITICAL ILLNESS. THE PATIENT WAS STABILIZED AND THE PHYSICIAN WAS VERY SATISFIED WITH THE USE OF THE DEVICE FOR THIS THERAPY. ALUNG WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE VIEW OF ALL ALUNG 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 ANEMIA DURING HEMOLUNG RAS EUA THERAPY AS WELL AS A HEMATOMA DEVELOPING AROUND THE CATHETER INSERTION POINT. MEDICAL INTERVENTION WAS NECESSARY BY STOPPING HEPARIN AND GIVING PROTAMINE SULFATE. HEMOLUNG EUA THERAPY WAS ELECTIVELY DISCONTINUED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465902 \HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19 QLN ALUNG TECHNOLOGIES, INC. HL-CR4-01-000 00850046004346

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Life Threatening| R