BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3000 INFUSION PUMP

    MDR report key: 515674 · Received March 12, 2004

    Report

    Report Number
    9612511-2004-00010
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    January 30, 2004
    Report Date
    March 12, 2004
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS FOUND TO BE HYPOTENSIVE AFTER A 10 MG BOLUS OF PROPOFOL BEING INFUSED VIA A VOLUMETRIC PUMP, BLOOD PRESSURE DROPPED TO 75/38 - PUMP WAS SWITCHED OFF BUT NURSES NOTICED DRIPPING IN THE DRIP CHAMBER. ROLLER CLAMP TURNED OFF (WHICH WAS STILL OPEN) PUMP DOOR OPENED AND EVERYTHING WAS AS IT SHOULD BE. DOCTOR INFORMED AND EPHEDRINE ADMINISTERED. PT'S BLOOD PRESSURE IMPROVED. SET AND PUMP REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3000 INFUSION PUMP INFUSION PUMP FRN GRASEBY MEDICAL LTD. VOLUMETRIC PUMP (GRASEBY 500) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 1. LARGE VOLUME ADMINISTRATION SET - PART AND LOT| NUMBER UNK.