BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1230107 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88563
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 19, 2007
    Report Date
    June 20, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Removal / Correction Number
    6000001/06/21/0/-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 JUN 26 2007. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON RECEIPT OF THE EVALUATION. THE 16:310:867:0002 IS DUE TO A SOFTWARE "MAILBOX", THAT STORES TEMPORARY DATA UNTIL IT CAN BE PROCESSED, BECOMING FILLED. THE ISSUE IDENTIFIED ABOVE HAS BEEN REPRODUCED IN OUR FACILITY WITH USER INTERFACE SOFTWARE VERSIONS 5.09.90 AND 6.13.90. PRELIMINARY ANALYSIS INDICATES THAT THIS ISSUE OCCURS ON TRIPLE CHANNEL DEVICES, DURING USER PROGRAMMING, WITH THREE CHANNELS INFUSING, IN SPECIFIC USE CASE SCENARIOS. ANALYSIS OF FIELD INFORMATION AND THE DATA, EVENT LOGS AND THE ISSUE INVESTIGATION HAVE NOT SHOWN THAT THE ISSUE WILL OCCUR ON PREVIOUS SOFTWARE VERSIONS IN THE SAME USE CASE SCENARIO. THERE IS NO EVIDENCE THAT THIS CAN OCCUR ON SINGLE CHANNEL DEVICES. ROOT CAUSE INVESTIGATIONS ARE CONTINUING. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA. PLEASE NOTE, IN REFERENCE TO THE "COLLEAGUE TRIPLE CHANNEL" ISSUE DESCRIBED IN THIS REPORT, AND BASED ON THE REVIEW OF RELEVANT COMPLAINT HISTORY OF THIS AND SIMILAR EVENTS, BAXTER DECIDED IN 2007, TO TAKE "REMEDIAL ACTION" TO PREVENT RISK OF HARM TO THE PUBLIC HEALTH. BASED ON THIS DECISION, A 5-DAY MDR WAS INITIATED FOR ALL EVENTS ASSOCIATED WITH THIS ISSUE. AS SUCH, THE AWARE DATE IS 2007, FOR ALL REPORTED EVENTS RECEIVED PRIOR TO THIS DATE.

    Description of Event or Problem · 1

    THE FACILITY BIOMEDICAL MANAGER ADVISED THAT HE HAS BEEN MADE AWARE THAT A COLLEAGUE TRIPLE CHANNEL PUMP ALARMED WITH A FC16:310, AND STOPPED INFUSING ON ALL CHANNELS DURING PATIENT USE. THE DEVICE HAS BEEN SEQUESTERED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP 80 FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1