BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 405476 · Received July 16, 2002

    Report

    Report Number
    405476
    Event Type
    Death
    Date Received
    July 16, 2002
    Date of Event
    May 13, 2002
    Report Date
    July 16, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TOTAL PARENTERAL NUTRITION ADMINISTERED THROUGH A PUMP TO A CENTRAL LINE. PUMP WAS SET AT 650 CC/HR (NURSE THOUGHT SHE ENTERED 65/HR). PT RECEIVED 1600 CC IN THE LESS THAN 3HR. PT BECAME CONFUSED WITH RESPIRATORY DISTRESS PROGRESSING TO COMATOSE STATE AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT XL 3M IV PUMP FRN ABBOTT LABORATORIES XL3M *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death