BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 552571 · Received October 6, 2004

    Report

    Report Number
    552571
    Event Type
    Death
    Date Received
    October 6, 2004
    Date of Event
    October 2, 2004
    Report Date
    October 6, 2004
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    FPK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH NAUSEA AND VOMITING WAS SEEN IN THE EMERGENCY ROOM. THE PATIENT WAS PREPARED FOR AN ABDOMINAL CT SCAN FOR RECTAL BLEEDING, WHICH REQUIRED AN INDWELLING INTRAVENOUS CATHETER AND EXTENSION TUBING TO BE PLACED. THE PATIENT WAS NOT RECEIVING IV FLUIDS OR MEDICATIONS AT THE TIME. THE PATIENT'S BLOOD PRESSURE WAS BEING MONITORED WHILE WAITING TO HAVE THE CT SCAN. THE HOSE TO THE CUFF WAS DISCONNECTED AND THE CUFF REMAINED ON THE PATIENT'S ARM WHENEVER THE PATIENT WENT TO THE RESTROOM. AFTER THE SECOND RETURN FROM THE RESTROOM THE PATIENT WAS LEFT ALONE. THE PATIENT'S SPOUSE RETURNED AND FOUND THE PATIENT BLUE FROM THE NECK UP. CPR WAS IMMEDIATELY INITIATED. A SECOND NURSE IN THE ROOM DISCOVERED THAT THE BLOOD PRESSURE MONITOR HOSE WAS ATTACHED TO THE PATIENT'S INDWELLING CATHETER. THE FIRST NURSE DID NOT CONNECT THE BLOOD PRESSURE MONITOR HOSE TO THE PATIENT'S IV EXTENSION TUBING. THE PATIENT RECEIVED APPROXIMATELY 15CC'S OF AIR THROUGH THE CATHETER CAUSING RESPIRATORY ARREST AND DEATH. A REPORT WAS FILED WITH THE POLICE AND AN AUTOPSY WAS PERFORMED. THE RESULTS CONFIRMED DEATH FROM AN AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT 2 MONITOR BLOOD PRESSURE MONITOR FPK DATASCOPE CORPORATION PASSPORT XG *
    2 PASSPORT 2 MONITOR BLOOD PRESSURE HOSE DXN DATASCOPE CORPORATION * *
    3 ABBOTT LIFE SHIELD MICROBORE EXTENSION SET EXTENSION TUBING SET FPA HOSPIRA GLOBAL MEDICAL AFFAIRS * 18052NS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death OTHER