BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200113 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00069
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    September 13, 2020
    Report Date
    January 18, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004346
    PMA / PMN Number
    DEN210006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PATIENT INFORMATION WAS NOT PROVIDED. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN PALM BEACH GARDENS, FLORIDA. THERE WAS NO REPORT OF PATIENT INJURY. DURING EUA HEMOLUNG THERAPY, SITE STAFF REPORTED EXPERIENCING A CS10 CO2 SENSOR FAILURE ALARM ON THE CONTROLLER. CLINICAL SUPPORT WAS PROVIDED IN WHICH IT WAS DISCUSSED TO UTILIZE THE BLOOD GAS VALUES TO MONITOR CO2 LEVELS UNTIL THE CONTROLLER WOULD BE CHANGED OUT. THIS ISSUE DID NOT CAUSE THERAPY TO END. SITE WAS SATISFIED WITH CUSTOMER SUPPORT PROVIDED. NO CLINICAL COMPLICATIONS WERE REPORTED AS TO HAVE OCCURRED AS A RESULT OF THIS ISSUE. ON SITE REPAIR INCLUDED REPLACEMENT OF THE SBA-5 BOARD ON THE CONTROLLER. THE CONTROLLER THEN PASSED ALL TESTING WITHOUT ISSUE. THE REMOVED BOARD WAS RETURNED TO THE ENGINEERING DEPARTMENT FOR FURTHER EVALUATION. DURING ENGINEERING ANALYSIS, THE BOARD RAN APPROXIMATELY 1250 HOURS WITHOUT ANY ANOMALIES OBSERVED. THIS ERROR WAS UNABLE TO BE RECREATED. THE DATA LOG FROM THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. NO ABNORMALITIES WERE NOTED WITHIN THE CO2 REMOVAL AND BLOOD FLOW GRAPHS. THE CS-10 ALARM WAS OBSERVED WITHIN THE DATA LOG AS OCCURRING . EVALUATION OF THIS ALARM SHOWED THAT THE SENSOR CALIBRATION/BASELINE WAS NOT CORRECT FOR 2 CYCLES, IN WHICH THE SENSOR IS ZEROED EVERY 20 MINUTES. THE SENSOR THEN CORRECTED ITSELF AND THE VALUES RETURNED AS EXPECTED FOR THE REMAINDER OF THE THERAPY. THERAPY WAS PROVIDED AS INTENDED. ALUNG TECHNOLOGIES, INC. WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. 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 THAT DURING EUA HEMOLUNG THERAPY A CS10 CO2 SENSOR FAILURE ALARM WAS SEEN ON THE CONTROLLER. THERAPY WAS PROVIDED AS INTENDED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129491 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 66 YR Female