BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVAC SPACE SAVER

    MDR report key: 117933 · Received September 4, 1997

    Report

    Report Number
    117933
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    August 15, 1997
    Report Date
    September 2, 1997
    Manufacturer
    IVAC MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NTG DRIP STARTED AT 12:42. IVAC PUMP #773 OVER INFUSED - PT REC'D 100 CC NTG. OVER INFUSION NOTED AT 12:46 - HEART RATE DROPPED TO 43. HEAD LOWERED, TURNED OFF IVAC, HEART RATE BEGAN TO RISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVAC SPACE SAVER IV PUMP FRN IVAC MEDICAL SYSTEMS 773 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention