BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160904 · Received September 17, 2008

    Report

    Report Number
    6000001-2007-04742
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED 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 MAR 01 2007. EVALUATION SUMMARY:THE REPORTED CONDITION OF PUMP WITH FAILURE CODE 40:430:259:920 COULD NOT BE CONFIRMED DUE TO FAILURE CODE 199:117:307:0000 FOUND IN THE PUMP'S EVENT HISTORY WHICH CAUSES ALL HISTORIES TO BE DELETED. FAILURE CODE 40:430:259:920 IS A NONEXISTENT FAILURE CODE FOR THE COLLEAGUE INFUSION PUMP AND IS NOT FOUND IN THE OPERATION MANUAL. WRITER CALLED THE FACILITY TO CONFIRM THE FAILURE CODE AND FOUND THAT THERE WAS A FAILURE CODE BUT IT WAS UNKNOWN TO THE FACILITY AS TO WHAT THE EXACT FAILURE CODE WAS THAT THEY ENCOUNTERED. THE PUMP'S BATTERIES WERE REPLACED TO CORRECT FAILURE CODE 199:117:307:0000. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CUSTOMER SERVICE A PUMP WITH FAILURE CODE 40:430:259:920 WHICH RESULTED IN NON-DELIVERY DURING INFUSION OF PROPOFOL 10 MCG/KG/MIN AT A RATE OF 6.8 ML/HR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. THE DATE THAT THIS WAS DETERMINED TO BE A REPORTABLE EVENT WAS 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1