BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1023981 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-04045
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    January 12, 2007
    Report Date
    January 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE CODE 812:02 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY FILE DURING PRODUCT EVALUATION. THIS FAILURE CODE WAS CAUSED BY A FAULTY PUMP HEAD MECHANISM CHANNEL A. PUMP MECHANISM CHANNEL A WAS THEREFORE REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, FAILURE CODE 812:02 WAS IDENTIFIED IN THE PUMP'S EVENT HISTORY FILE. 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