BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVAC NEOMATE INFUSION PUMP

    MDR report key: 42912 · Received September 26, 1996

    Report

    Report Number
    42912
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    August 19, 1996
    Report Date
    August 27, 1996
    Manufacturer
    IVAC CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOPAMINE DRIP STARTED AT RATE OF 0.3 CC/HR USING INFUSION PUMP. TWENTY MINS LATER, NEWBORN'S BLOOD PRESSURE WAS 140/117. DOPAMINE DRIP STOPPED. TOTAL VOLUME INFUSED IN 20 MINS WAS 0.7 CC. NEWBORN'S BLOOD PRESSURE RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVAC NEOMATE INFUSION PUMP INTRAVENOUS INFUSION PUMP FRN IVAC CORP. 565 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention