BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFE-T-CARE

    MDR report key: 244471 · Received October 9, 1999

    Report

    Report Number
    244471
    Event Type
    Injury
    Date Received
    October 9, 1999
    Date of Event
    September 28, 1999
    Report Date
    September 29, 1999
    Manufacturer
    CHILDREN'S MEDICAL VENTURES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IV SOLUTION WAS DELIVERED TO PT AT APPROX 20 TIMES INTENDED RATE. INSPECTION OF SET UP REVEALED STOPCOCK SETTING ALLOWED FLOW OF IV SOLUTION FROM SUPPLY AS WELL AS SYRINGE PUMP. CLOSER INSPECTION OF IV TUBING SET REVEALED A LACK OF A SAFETY STOP THAT WOULD PREVENT FLOW FROM 2 SOURCES. IT IS NOT KNOWN AT THIS TIME IF THE SAFETY STOP WAS PACKAGED WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-CARE IV INFUSION SET FPA CHILDREN'S MEDICAL VENTURES 92062-H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Hospitalization| R NO RELATED DEVICES.