BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1232089 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-88570
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    June 17, 2007
    Report Date
    June 19, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Removal / Correction Number
    6000001-06/21/07-004-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HAS BEEN REQUESTED BY BAXTER QUALITY MANAGEMENT FOR EVALUATION BUT HAS NOT YET BEEEN RECEIVED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITOAL 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. 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 06/20/2007 FOR ALL REPORTED EVENTS RECEIVED PRIOR TO THIS DATE.COMPLAINT NO: CMPLNT-000037912

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE BIOMEDICAL MANAGER OF AN INCIDENT INVOLVING THE UPGRADED COLLEAFUE PUMP WHICH HFAILED DURING PATIENT INFUSION WITH FAILURE CODE 16:310. THE PATIENT WAS A 4 HOUR POST-OPERATIVE CARDIAC TRANSPLANT PATIENT WHO WAS RECEIVING TWO VASOACTIVE DRIPS WHEN THE PUMP HAD FAILED IN '07 AT 0845. THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 40'S SYSTOLIC. THE PATIENT WAS GIVEN TWO BOLUSES OF EPINEPHRINE TO PREVENT CARDIAC ARREST. THE PATIENT BECAME HYPERTENSIVE AND WAS GIVEN A NITROGLYCERIN BOLUS TO STABILIZE THE BLOOD PRESSURE. THE RISK MANAGER WSA CONTACTED AND DID NOT HAVE ANY ADDITIONAL CLINICAL INFORMATION TO PROVIDE.

    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 Life Threatening| R