BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1230140 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88578
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 24, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Removal / Correction Number
    6000001-06/21/07-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE AND PUMP HISTORY HAVE BEEN REQUESTED BY BAXTER QUALITY MANAGEMENT FOR EVALUATION. THE FACILITY STATED THE DEVICE WILL BE SENT FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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.

    Description of Event or Problem · 1

    A BAXTER REPRESENTATIVE STATING THE SHE HAS AN EVENT HISTORY AND PUMP WHICH HAD FAILURE CODE 16:310 REPORTED BY THE FACILITY. THERE WAS NO INCIDENT REPORT ATTACHED TO THE PUMP AND THEREFORE NO ADDITIONAL INFORMATION REGARDING ANY PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1