BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLUNG RAS

    MDR report key: 16211821 · Received January 19, 2023

    Report

    Report Number
    3009763347-2023-00074
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    May 25, 2020
    Report Date
    January 19, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004346
    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 STEVENAGE, UNITED KINGDOM . IT WAS REPORTED THAT DURING THERAPY, STAFF EXPERIENCED A CRITICAL 102 ERROR. THE CONTROLLER RESPONDED APPROPRIATELY BY STOPPING THE BLOOD PUMP. CUSTOMER SERVICE WAS PROVIDED IN WHICH THEY ADVISED TO DISCONNECT THE O2, RESTART THE CONTROLLER, AND EVALUATE THE CIRCUIT. HOWEVER, AFTER INSPECTING THE CIRCUIT, THE PHYSICIAN FELT IT WAS UNSAFE TO ATTEMPT TO RESTART THERAPY. CUSTOMER SUPPORT WAS PROVIDED THROUGH ENDING THERAPY. THE PATIENT WAS ASSESSED THE FOLLOWING DAY AND THE SITE STAFF CONFIRMED THE PATIENT WAS SEEMINGLY UNAFFECTED BY THE ISSUE WITH THE CONTROL. FOLLOWING THE DISCONTINUATION OF THERAPY, A REPLACEMENT CONTROLLER WAS INSTALLED AND TESTING WITHOUT ISSUE. SITE STAFF WAS SATISFIED WITH THE SUPPORT PROVIDED AND THE EQUIPMENT REPLACEMENT. THE REMOVED CR4 CONTROLLER WAS RETURNED TO AVENSYS FOR REPAIR. THROUGH REVIEW OF THE DATA LOG, IT WAS DETERMINED THAT THERE WAS A LEAK FROM THE OXYGEN SWEEP GAS. THIS CONTROLLER WAS RECERTIFIED, WITH TUBINGS REPLACED, AND PASSED ALL TESTING WITHOUT ISSUE. 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. THERAPY WAS PROVIDED AS INTENDED. SITE STAFF WAS SATISFIED WITH THE SUPPORT PROVIDED AND THERE WERE NO CLINICAL COMPLICATIONS REPORTED AS TO HAVE OCCURRED AS A RESULT OF THE ALARM. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. EXAMINATION OF THE CONTROLLER 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 THAT DURING EUA HEMOLUNG THERAPY, STAFF EXPERIENCED A CRITICAL 102 ERROR. THE CONTROLLER RESPONDED APPROPRIATELY BY STOPPING THE BLOOD PUMP. CUSTOMER SERVICE WAS PROVIDED IN WHICH THEY ADVISED TO DISCONNECT THE O2, RESTART THE CONTROLLER, AND EVALUATE THE CIRCUIT. HOWEVER, AFTER INSPECTING THE CIRCUIT, THE PHYSICIAN FELT IT WAS UNSAFE TO ATTEMPT TO RESTART THERAPY. CUSTOMER SUPPORT WAS PROVIDED THROUGH ENDING THERAPY. THE PATIENT WAS ASSESSED THE FOLLOWING DAY AND THE SITE STAFF CONFIRMED THE PATIENT WAS SEEMINGLY UNAFFECTED BY THE ISSUE WITH THE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363318 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 Female