BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER

    MDR report key: 502757 · Received December 11, 2003

    Report

    Report Number
    502757
    Event Type
    Injury
    Date Received
    December 11, 2003
    Date of Event
    October 7, 2003
    Report Date
    December 10, 2003
    Manufacturer
    BAXTER HEALTHCARE, MEDICATION DELIVERY SYSTEM QM DIVISION RLT-10
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING TPN AND OCTREOTIDE ON COLLEAGUE 3 CHANNEL PUMP-NO CHANGES MADE TO PUMP AT TIME OF FAILURE. ALARM WAS AUDIBLE WITH 2 CHANNELS READING "FAILURE" ON DISPLAY SCREEN. PUMP REMOVED FROM SERVICE. CLINICAL ENGINEERING REVIEWED ISSUES ON PUMP-CONFIRMED FAILURE 12:303:984:0002-SOFTWARE FAILURE INVALID VALUE. OVERFLOW IN COMMUNICATIONS CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER TRIPLE CHANNEL PUMP FRN BAXTER HEALTHCARE, MEDICATION DELIVERY SYSTEM QM DIVISION RLT-10 * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention