BEUDAMED
    FDA Adverse Event Death Summary report: N

    THOPAZ+ CHEST DRAINAGE SYS

    MDR report key: 24079523 · Received January 15, 2026

    Report

    Report Number
    1419937-2026-00002
    Event Type
    Death
    Date Received
    January 15, 2026
    Date of Event
    January 3, 2026
    Report Date
    March 25, 2026
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367043298
    PMA / PMN Number
    K141553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MEDELA AG HAS INITIATED THE IMMEDIATE RETURN OF THE AFFECTED DEVICE FOR INVESTIGATION TO DETERMINE IF ANY DEVICE MALFUNCTION OR CONTRIBUTION OF THE AFFECTED DEVICE TO THE INCIDENT HAS OCCURRED. THE LOG FILE OF THE AFFECTED DEVICE WAS READ OUT AND ANALYZED BY INTERNAL SUBJECT MATTER EXPERTS AS WELL AS AN EXTERNAL MEDICAL EXPERT IN THE FIELD OF CARDIOTHORACIC SURGERY. ACCORDING TO THE DATA OF THE LOG FILE AND THE RESPECTIVE ANALYSIS IT WAS CONCLUDED BOTH BY THE INTERNAL EXPERTS AS WELL AS THE EXTERNAL MEDICAL EXPERT THAT THE AFFECTED DEVICE PERFORMED AS INTENDED AND NO PRODUCT MALFUNCTION WAS IDENTIFIABLE. AN OVERALL INVESTIGATION INCLUDING TECHNICAL ANALYSIS OF THE AFFECTED DEVICE, REVIEW OF RISK MANAGEMENT FILES, REVIEW OF POST MARKET SURVEILLANCE DATA AND INCLUSION OF EXTERNAL MEDICAL EXPERT HAS BEEN INITIATED. AFTER THE ASSESSMENT OF THE INCIDENT WITH THE EXTERNAL MEDICAL EXPERT A SET OF ADDITIONAL QUESTIONS WAS DEFINED AND SHARED WITH THE HOSPITAL. THESE QUESTIONS CONTAIN CLARIFICATIONS ON THE CLINICAL BACKGROUND AND INFORMATION OF THE PATIENT, DETAILS ABOUT CHEST DRAINAGE MANAGEMENT AND USED PROTOCOLS, DETAILED SEQUENCE OF EVENTS OF THE INCIDENT AS WELL AS HOW THE DIAGNOSIS OF SUBCUTANEOUS EMPHYSEMA AND TENSION PNEUMOTHORAX WAS MADE AND WHAT TREATMENT/ACTIONS WERE IMPLEMENTED. THE ANSWERS ON THESE QUESTIONS ARE NECESSARY FOR MEDELA AG TO PERFORM A FINAL ASSESSMENT WITH THE EXPERTISE OF INTERNAL SUBJECT MATTER EXPERTS FROM RISK MANAGEMENT, CLINICAL, DESIGN & DEVELOPMENT AS WELL AS THE EXTERNAL MEDICAL EXPERT. SO FAR, EVEN AFTER A REMINDER, THE HOSPITAL REMAINS UNRESPONSIVE TO THE FOLLOW-UP QUESTIONS.

    Additional Manufacturer Narrative · 0

    THE PATIENT UNDERWENT A RIGHT LUNG WEDGE RESECTION ON (B)(6) 2025. DURING THE SURGERY, A BLAKE DRAIN WAS PLACED IN THE PLEURAL CAVITY AND CONNECTED TO A THOPAZ DEVICE. ON (B)(6), THE PATIENT WAS ACCIDENTALLY DROPPED WHILE IN THE BATHROOM, CAUSING THE THOPAZ DEVICE TO FALL TO THE FLOOR. THE PLASTIC COLLECTION CANISTER DETACHED, AND A LARGE AMOUNT OF AIR LEAKED OUT. THE PLASTIC CANISTER AND TUBING WERE REPLACED AND WERE FOUND TO FUNCTION NORMALLY. OVER THE FOLLOWING DAYS, THE PATIENT DEVELOPED EXTENSIVE SUBCUTANEOUS EMPHYSEMA, AND ON THE MORNING OF (B)(6) 2026, A TENSION PNEUMOTHORAX DEVELOPED, EVEN THOUGH THE DRAIN WAS IN PLACE AND SUCTION WAS APPLIED. A TENSION PNEUMOTHORAX SHOULD NOT DEVELOP WHILE A DRAIN IS IN SITU; THEREFORE, A DEVICE MALFUNCTION IS SUSPECTED. A SUDDEN CARDIAC ARREST OCCURRED, LEADING TO RESUSCITATION ATTEMPTS AND ULTIMATELY DEATH ON (B)(6) 2026.

    Description of Event or Problem · 0

    ON (B)(6) 2026, IT WAS REPORTED TO MEDELA LLC BY MEDELA AG THAT A THOPAZ PLUS WAS PLACED ON A PATIENT WHO LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142627 THOPAZ+ CHEST DRAINAGE SYS NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 079.1002 0000644600 07612367043298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death