BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 141130 · Received December 31, 1997

    Report

    Report Number
    141130
    Event Type
    Death
    Date Received
    December 31, 1997
    Date of Event
    August 18, 1997
    Report Date
    August 18, 1997
    Manufacturer
    ABBOTT CRITICAL CARE SYSTEMS
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CHANGE IN SWAN-GANZ CATHETER WAVEFORM AND PRESSURES WERE NOTED WHICH INDICATED POSSIBLE SUPERWEDGE POSITION. THE BALLOON CATHETER WAS NOT INFLATED AT THE TIME OF THE CHANGE IN WAVEFORM. THE CATHETER WAS PULLED BACK AND NORMAL WAVEFORM RETURNED. APPROXIMATELY 30 SECONDS AFTER MANIPULATION TUBE OF THE CATHETER, BRIGHT RED BLOOD WAS NOTED IN THE ENDOTRACHEAL TUBE OF THE PT AND SHE HAD A CARDIAC ARREST. EFFORTS TO RESUSCITATE THE PT WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT Implant THERMODILUTION CATHETER DYG ABBOTT CRITICAL CARE SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death