BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1240416 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04924
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    September 21, 2006
    Report Date
    February 13, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE CODE 810:04 WHICH STOPPED THE DEVICE FROM INFUSING ON CHANNEL A DURING PATIENT USE WAS CONFIRMED IN THE PUMP'S EVENT HISTORY FILE DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE COULD NOT DUPLICATE THIS FAILURE CODE AND THEREFORE NO CORRECTIONS RELATED TOT HIS FAILURE CODE COULD BE PERFORMED ON THE DEVICE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 810:04. THIS PROBLEM WAS IDENTIFIED DURING PATIENT USE DURING INFUSION AND THEREFORE THE INFUSION WAS STOPPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1