BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVI 3000

    MDR report key: 306965 · Received November 29, 2000

    Report

    Report Number
    306965
    Event Type
    Injury
    Date Received
    November 29, 2000
    Date of Event
    October 23, 2000
    Report Date
    November 10, 2000
    Manufacturer
    SIMS-DELTEC
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV PUMP DID NOT ALARM WHEN PT'S IV WENT SQ AND MUCH FLUID WAS ALLOWED TO SEEP INTO PT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 3000 IV PUMP FRN SIMS-DELTEC 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Hospitalization| R