BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 119921 · Received September 13, 1997

    Report

    Report Number
    119921
    Event Type
    Injury
    Date Received
    September 13, 1997
    Date of Event
    September 3, 1997
    Report Date
    September 12, 1997
    Manufacturer
    ICU MED INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    48 YR OLD MALE WITH A DISSECTING AORTA ON ESMOLOL, NIPRIDE & NITROGLYCERINE, IN ORDER TO KEEP HIS SYSTOLIC BLOOD PRESSURE BELOW 120. FOUND 2 TIMES WITH THE BLUNT LOCKING CANNULA BROKEN AND IV MEDICATIONS RUNNING INTO THE BED. PT WAS COMATOSE. SYSTOLIC BLOOD PRESSURE MUST BE KEPT UNDER 120 TO KEEP ANEURYSM FROM RUPTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT BLUNT LOCKING CANNULA FPA ICU MED INC. * S7H061 OR S7H056

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening 2. IV PUMP.| 1. ARTERIAL LINE.