BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE CONSOLE

    MDR report key: 4794408 · Received May 21, 2015

    Report

    Report Number
    4794408
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 21, 2015
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A FLEXIBLE BRONCHOSCOPY AND CRYOSPRAY PROCEDURE FOR LUNG CANCER. USE OF THE CRYOSPRAY MACHINE CARRIES AN INHERENT RISK OF PNEUMOTHORAX. AT THE END OF THE PROCEDURE SHE BECAME BRADYCARDIC AND HYPOTENSIVE AND WAS FOUND TO HAVE PNEUMOTHORACIES FOR WHICH CHEST TUBES WERE INSERTED. SHE SUSTAINED VENTRICULAR FIBRILLATION AND REQUIRED RESUSCITATION AND TRANSFER TO AN ICU. SHE WAS SUBSEQUENTLY FOUND TO HAVE BRAIN METASTASIS. THE MANUFACTURER OF THE INVOLVED MACHINERY RECENTLY HAD ISSUED AN ADVISORY NOT TO USE IT FOR "PASSIVE VENTING PROCEDURES" (E.G. BRONCHOSCOPY) DUE TO A .005% CHANCE OF MALFUNCTION. DURING THE PROCEDURE THERE WAS NO EVIDENCE OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331443 TRUFREEZE CONSOLE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL CC3-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR