BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI-FLOW 4000 PLUS

    MDR report key: 219159 · Received April 15, 1999

    Report

    Report Number
    MW1016136
    Event Type
    Injury
    Date Received
    April 15, 1999
    Report Date
    February 1, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO OUT OF THREE OMNI-FLOW PLUS INFUSION PUMPS ALARMED, "CHANNEL A OCCLUSION" AND "AIR ELIMINATION BAG FULL" WHICH RESULTED IN SEVERE HYPOTENSION FOR A POST-OPERATIVE OPEN HEART PT WHO WAS VERY DEPENDENT ON IV VASOPRESSORS TO MAINTAIN AN ADEQUATE BLOOD PRESSURE. ONCE CHANNEL "A" BEGAN ALARMING ON TWO PUMPS SIMULTANEOUSLY, STAFF WAS UNABLE TO CORRECT THE ALARMS AND IT APPEARED THAT THE OTHER CHANNEL'S (B,C,D) WERE NOT FUNCTIONING EITHER, RELATED TO THE RESULTANT SEVERE HYPOTENSION. THE PT REC'D AN INTRA-AORTIC BALLOON PUMP AS A RESULT OF THIS EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-FLOW 4000 PLUS INFUSION PUMP FRN ABBOTT LABORATORIES, INC. OMNI-FLOW 4000 PLUS *
    2 OMNI-FLOW 4000 PLUS INFUSION PUMP FRN ABBOTT LABORATORIES, INC. OMNI-FLOW 4000 PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention