BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW PNEUMOTHORAX KIT

    MDR report key: 354821 · Received October 5, 2001

    Report

    Report Number
    1036844-2001-00075
    Event Type
    Death
    Date Received
    October 5, 2001
    Date of Event
    September 1, 2001
    Report Date
    October 3, 2001
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PNEUMOTHORAX PROCEDURE, THE PT SUSTAINED A LACERATION OF THE AORTA, DEVELOPED CARDIAC TAMPONADE, AND EXPIRED. THE PT HAD BEEN PLACED ON A VENTILATOR DUE TO A PNEUMOTHORAX RELATED TO AN UNSUCCESSFUL CENTRAL LINE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45084 ARROW PNEUMOTHORAX KIT PNEUMOTHORAX KIT CAZ ARROW INTERNATIONAL INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death