BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 539654 · Received August 5, 2004

    Report

    Report Number
    539654
    Event Type
    Injury
    Date Received
    August 5, 2004
    Date of Event
    June 5, 2004
    Report Date
    August 5, 2004
    Manufacturer
    ABBOTT LABORATORIES, INC
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE OMNI FLOW PUMP FAILED. STOPPED PUMPING IV FLUIDS WHILE PATIENT DEPENDENT ON EPINEPHRINE AND DOPAMINE DRIPS RESULTING IN PATIENT'S SYSTOLIC BP, BLOOD PRESSURE, DROPPING TO THE 50'S AND THE PATIENT BECAME NONRESPONSIVE. PATIENT BAGGED FOR ABOUT 2 MINUTES WHILE PUMP WAS CHANGED OUT. THEN PATIENT BECAME ORIENTED AND ALERT AFTER BLOOD PRESSURE REBOUNDED TO 90'S. NON-REBREATHER PLACED ON PATIENT AND WAS SUCTIONED MULTIPLE TIMES TO CLEAR AIRWAY. PATIENT NEVER LOST PULSE. ABG'S, ARTERIAL BLOOD GAS, TAKEN ON NRB, NON-REBREATHER. PHYSICIAN NOTIFIED OF THE ENTIRE INCIDENT. OMNI FLOW PUMP LABELED "NON-FUNCTIONAL" AND PLACED IN BIOHAZARD ROOM. (EQUIPMENT SEQUESTERED) AND SENT TO BIOMED FOR EVALUATION. PROBLEM COULD NOT BE REPRODUCED BY BIOMED. ULTIMATELY, PATIENT IMPROVED AND PATIENT HAD NO FURTHER DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OMNI FLOW IV PUMP FRN ABBOTT LABORATORIES, INC 4000 CE 30120

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention