BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIM PLUS

    MDR report key: 87997 · Received May 1, 1997

    Report

    Report Number
    MW1011231
    Event Type
    Injury
    Date Received
    May 1, 1997
    Date of Event
    March 16, 1997
    Report Date
    April 21, 1997
    Manufacturer
    ABBOTT LABORATORIES INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ORDERED TO RECEIVE 5 FU 240 MG/DAY X 5 DAYS VIA PUMP. PATIENT WAS SEEN ON 3/16/97 BY RN TO CHANGE MEDICATION BAG AND SET UP PUMP. PUMP WAS NOT PRE-PROGRAMMED AND THE RN HAD TO PROGRAM THE PUMP WITH THE ASSISTANCE OF THE ON-CALL PHARMACIST. THE ON-CALL RN RECEIVED A CALL FROM THE FAMILY 5 HOURS LATER STATING THAT THE PUMP WAS "BEEPING" AND THE BAG WAS EMPTY, INDICATING THAT THE PATIENT RECEIVED THE ENTIRE 5 DAY DOSE IN APPROX. 4 1/2 HOURS. PT EXPERIENCEING NAUSEA & VOMITING. PT SENT TO ER AND WAS EVENTUALLY HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIM PLUS AMBULATORY INFUSION PUMP FRN ABBOTT LABORATORIES INC. PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L