BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMED

    MDR report key: 207672 · Received December 18, 1998

    Report

    Report Number
    207672
    Event Type
    Injury
    Date Received
    December 18, 1998
    Date of Event
    August 16, 1998
    Report Date
    September 24, 1998
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT PLACED ON ECMO ATG 1800 8/16/1998. INTRAVENOUS PUMPS READ HOURLY. AT APPROXIMATELY 0100 08/17/1998 THE NURSE NOTED 20CC MORE HEPARIN HAD INFUSED THAN WAS EXPECTED. THE INFANT'S BLEEDING TIMES WERE VERY PROLONGED REQUIRING NUMEROUS UNITS OF ADDITIONAL CLOTTING AGENTS. THE PUMP WAS RETURNED TO BIOMEDICAL SERVICES FOR REPAIR. BIOMEDICAL SERVICES WAS NOT ABLE TO DUPLICATE THE PROBLEM. THE PUMP WAS RETURNED TO THE MFG FOR KEYSTROKE LOG ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED INFUSION PUMP FRN ALARIS MEDICAL SYSTEMS, INC. 1340 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening