BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1200825 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-00227
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 03, 2007. EVALUATION SUMMARY:EVALUATION WAS PERFORMED AND THE REPORTED CONDITION OF FAILURE CODE 812:02 WAS CONFIRMED. INSPECTION OF THE PUMP REVEALED DEFECTIVE PUMP HEAD MODULE ON CHANNEL A CAUSED FAILURE CODE 812:02. THE PUMP HEAD MODULE ON CHANNEL A WAS REPLACED. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH FAILURE CODE 812:02 ON CHANNEL A. THIS EVENT OCCURRED DURING BIO-MED TESTING. 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