BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACE LAB

    MDR report key: 340374 · Received July 3, 2001

    Report

    Report Number
    340374
    Event Type
    Death
    Date Received
    July 3, 2001
    Date of Event
    July 2, 2001
    Report Date
    July 2, 2001
    Manufacturer
    SPACE LAB MEDICAL
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STARTED PERIPHERAL IV TO THE RIGHT ANTECUBITAL. LABWORK WAS DRAWN AND CATHETER WAS HEPLOCKED. B/P CUFF WAS CONNECTED PRIOR TO THE IV BEING STARTED. REMOVED THE B/P CUFF TO GAIN ACCESS TO THE RIGHT ANTECUBITAL. AFTER ACCESS TO ANTECUBITAL WAS OBTAINED, PLACED THE B/P CUFF BACK ON THE RIGHT ARM. B/P TUBING WAS REMOVED TO PROPERLY DEFLATE CUFF FOR PROPER FIT. WHEN CONNECTING B/P TUBING BACK TO THE CUFF, IT WAS INADVERTENTLY CONNECTED TO THE HEPLOCK IV. THE B/P CUFF TUBING AND PERIPHERAL IV HEPLOCK WERE IN CLOSE PROXIMITY TO ONE ANOTHER. CONNECTORS ON HEPLOCK AND B/P TUBING WERE COMPATIBLE. THE INTERNAL ALARM INVESTIGATION AS TO WHETHER THE ALARM ACTIVATED IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30001 SPACE LAB NIBP MODULE DXN SPACE LAB MEDICAL 90467 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death