BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THOROGUARD

    MDR report key: 22329305 · Received June 24, 2025

    Report

    Report Number
    MW5171897
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    June 2, 2025
    Report Date
    June 14, 2025
    Manufacturer
    CENTESE, INC.
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    POST OPERATIVELY THE CHEST TUBE WAS CONNECTED TO THOROGUARD. ON (B)(6) 2025, POST-OP DAY 1, REVIEW OF THE SCHEDULED MORNING X-RAY BY SHOWED A LARGE LEFT SIDED PNEUMOTHORAX. IMMEDIATELY THE SURGEON WENT TO BEDSIDE AND FOUND THE PATIENT TO BE ASYMPTOMATIC WITH NO COMPLAINTS. THE PATIENT WAS WELL-APPEARING. THE SURGEON DISCONNECTED THE CHEST TUBE FROM THE THOROGUARD AND CONNECTED IT TO A PLEUR-EVAC. IMMEDIATELY THE AIR WAS RELEASED FROM THE LEFT SIDE. PATIENT REMAINED ASYMPTOMATIC THROUGHOUT THE EXCHANGE. THE THOROGUARD DID NOT DETECT AN AIR LEAK. AFTER THE THOROGUARD WAS DETACHED FROM THE PATIENT'S CHEST TUBE, THE MACHINE STILL DID NOT REGISTER AN AIR LEAK. INTERVAL DEVELOPMENT OF A LARGE LEFT PNEUMOTHORAX WITH LEFT UPPER LOBE COLLAPSE. THERE ARE POSTSURGICAL CHANGES IN THE LEFT UPPER LOBE. SLIGHT SHIFT OF THE CARDIAC SILHOUETTE TOWARDS THE RIGHT COMPARED TO PRIOR EXAMS. NO PLEURAL EFFUSIONS ARE SEEN. THE RIGHT LUNG IS CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128883 THOROGUARD PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA CENTESE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Required Intervention