BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1240273 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06242
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 11, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE EVALUATED ON 01/22/2007. FAILURE CODE 812:02 WAS CONFIRMED. THE DEVICE WAS RETURNED UNREPAIRED, PER CUSTOMER REQUEST, DUE TO ESTIMATE REFUSAL.ISSUES ASSOCIATED WITH FAILURE CODE 812:02 WILL BE ADDRESSED IN THE COLLEAGUE DEPLOYMENT PROGRAM. AT THE TIME OF THIS REPORT, REVIEW OF TRENDING REVEALED A POSITIVE TREND (DECREASING OCCURRENCE) FOR THE REPORTED FAILURE CODE 812:02. AN INITIAL MEDWATCH AND FOLLOW-UP MEDWATCH #1 WERE SENT IN ERROR UNDER MFR. REPORT # 1423500-2007-00047. ALL OF THE DATA CONTAINED IN THE INITIAL AND FOLLOW UP MEDWATCHES FOR MFR. REPORT #1423500-2007-0047 ARE CONTAINED IN THIS INITIAL MEDWATCH.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH FAILURE CODE 812:02. INFORMATION WAS NOT PROVIDED REGARDED WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS 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. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1