BEUDAMED
    FDA Adverse Event Summary report: N

    OMNI

    MDR report key: 1191187 · Received August 14, 2008

    Report

    Report Number
    1191187
    Date Received
    August 14, 2008
    Date of Event
    June 15, 2008
    Report Date
    August 14, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    DURING THE NIGHT, THE OMNI PUMP BEEPED "LINE A OCCLUSION" WITHOUT THERE BEING AN OCCLUSION. STAFF IMMEDIATELY CHANGED THE TUBING TO DIFFERENT TUBING WITHOUT AFFECTING THE PATIENT. THE NEXT MORNING THE SECOND OMNI PUMP BEEPED "LINE A OCCLUSION" AGAIN WITHOUT THERE BEING AN OCCLUSION. STAFF HAD TO RESTART A NEW PUMP WITH NEW TUBING. THE PATIENT'S BLOOD PRESSURE DROPPED TO AN IMMEASURABLE LEVEL AND THE PATIENT MAINTAINED A BP BELOW 60 FOR APPROXIMATELY 10-15 MINUTES. THE PATIENT WAS VERY UNSTABLE BEFORE INCIDENT. BOTH PUMPS WERE MARKED FOR BIOMED (WITH THE TUBING IN PLACE) AND TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI PUMP, IV FRN HOSPIRA GLOBAL MEDICAL AFFAIRS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR