BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGE 3

    MDR report key: 510835 · Received February 3, 2004

    Report

    Report Number
    MW1031016
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Date of Event
    December 4, 2003
    Report Date
    December 31, 2003
    Manufacturer
    BAXTER PRODUCT SERVICE MGR
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IV PUMP FOUND TO BE UNDER DELIVERING GREATER THAN 5% OF THE TIME. REPORTER HAS FOUND BY RANDOM SAMPLE OF CHECKING THESE PUMPS, FIVE PUMPS NOW ARE UNDER DELIVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGE 3 IV PUMP FRN BAXTER PRODUCT SERVICE MGR * *
    2 COLLEAGE 3 IV PUMP FRN BAXTER PRODUCT SERVICE MGR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other