BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNI FLO PUMP

    MDR report key: 31997 · Received January 10, 1995

    Report

    Report Number
    31997
    Event Type
    Death
    Date Received
    January 10, 1995
    Date of Event
    December 12, 1994
    Report Date
    December 20, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN STATES IN DISCHARGE SUMMARY THERE WAS A PROBLEM WITH THE IV PUMP ADMINISTERING THE INOTROPIC AGENTS ON THE WAY FROM SURGERY TO ICU. THE PUMP DID FAIL IN ICU AND WAS CHANGED OUT IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI FLO PUMP PUMP FRN ABBOTT LABORATORIES 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death