BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    MDR report key: 914443 · Received September 4, 2007

    Report

    Report Number
    6000001-2007-09468
    Event Type
    Death
    Date Received
    September 4, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 8, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE INDICATES THE REPORTED CONDITION OF FAIL CODE 16:310 WAS CONFIRMED BUT COULD NOT BE DUPLICATED DURING SERVICE. THE PUMP PASSED POWER ON SELF-TEST ON AC. THE FRONT BEZEL WAS OPENED & A VISUAL INSPECTION OF ALL WIRES, HARNESS CONNECTIONS, AND USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS PERFORMED. THE MASTER AND SLAVE SOFTWARE PROGRAMMABLE READ ONLY MEMORY WERE FOUND INSERTED CORRECTLY. NO VISUAL DAMAGE WAS FOUND. THE BATTERIES HAD 10 CHARGE/DISCHARGE CYCLES & 0 DISCHARGES BELOW ALARM THRESHOLD. THE PUMP PASSED THE KEYPAD TEST. THE DEVICE HAS BEEN RETURNED TO BAXTER TECHNICAL SERVICE FOR REPAIR. THE BUFFER OVERFLOW ISSUE RESULTING IN FAILURE CODE 16:310 FOUND IN THE SOFTWARE VERSION UTILIZED IN COLLEAGUE INFUSION PUMPS HAS BEEN FOUND TO BE REPEATABLE IN A SPECIFIC CLINICAL SITUATION, AND HAS RESULTED IN MULTIPLE PATIENT ADVERSE EVENTS OVER A SHORT PERIOD OF TIME FOLLOWING INITIATION OF DEPLOYMENT OF THIS SOFTWARE VERSION IN THE US. THE ISSUE IS CAUSED BY AN OVERFLOW IN THE MEMORY BUFFER THAT FEEDS THE MAIN PROCESSOR. THE C2006 SOFTWARE VERSION INCLUDES SEVERAL CHANGES THAT HAVE INCREASE THE UTILIZATION LEVEL OF THIS BUFFER, RESULTING IN A HIGHER PROBABILITY OF OVERFLOW. FOR THE VERSION OF SOFTWARE UTILIZED IN PUMPS OUTSIDE OF THE US (VB), INCLUDING THE ONE INVOLVED IN THIS COMPLAINT FROM ANOTHER COUNTRY, THE BUFFER UTILIZATION LEVEL IS SIGNIFICANTLY LOWER. THE COMPLAINT RATE FOR THE VB SOFTWARE IS APPROXIMATELY 1 COMPLAINT PER MILLION INFUSIONS (CPMI) AS COMPARED TO A COMPLAINT RATE OF 163 CPMI ON THE C2006 SOFTWARE. BASED ON THESE DIFFERENCES, COLLEAGUE INFUSION PUMPS WITH THE VB SOFTWARE ARE NOT CONSIDERED EQUIVALENT TO THOSE WITH THE C2006 SOFTWARE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE FAILURE CODE 16:310 OCCURRED ON THE PUMP DURING USE ON A PATIENT. THE PUMP WAS INFUSING PROPOFOL 50MCG/KG/MIN (SEDATION/ANESTHETIC) AND LEVOPHED 12MCG/HR (BP) AND INSULIN 2U/HR. ALL 3 CHANNELS FAILED. THE BLOOD PRESSURE OF THE PATIENT DROPPED AND HIS ICP (INTRACRANIAL PRESSURE) ROSE. MEDICAL INTERVENTION WAS REQUIRED TO AVOID PATIENT INJURY. THE INSULIN WAS INCREASED TO 2.5 U/HR, PROPOFOL WAS DECREASED TO 36 MCG/KG/MIN AND THE LEVOPHED WAS INCREASED TO 22.5MCG/HR. THE EVENT REPORTEDLY OCCURRED BETWEEN 0800 AND 0900 IN 2007. THE VITAL SIGNS AT 0700 WERE: BP 172/80, MAP (MEAN ARTERIAL PRESSURE) 108, P - 80 AND ICP (INTRACRANIAL PRESSURE) /CPP (CEREBRAL PERFUSION PRESSURE) 30/73. AT 0830 WERE: BP 188/80, MAP 110,9-82. AY 0900 WERE: BP 170/74, MAP 103, P-82, AND ICP/CCP - 34/70. THE PATIENT HAD IN PLACE A RIGHT FEMORAL CENTRAL LINE, A LEFT RADIAL ARTERIAL LINE, A FOLEY CATHETER, AND A FEEDING PUMP. THE PATIENT WAS ALSO ON A VENTILATOR. THE PATIENT WAS REPORTEDLY UNSTABLE AND IN CRITICAL CONDITION. THE PUMP WAS REPLACED AND THE PATIENT WAS STABILIZED BUT CONSIDERED CRITICAL. ON THE FOLLOWING MONTH, THE PATIENT WAS DECLARED BRAIN DEAD AND EXPIRED. THE CAUSE OF DEATH IS LISTED AS BRAIN DEATH. THE RISK MANAGER IS NOT SURE IF AN AUTOPSY WAS DONE. ORGANS WERE DONATED. NO LITIGATION IS PENDING AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death PAVULON (MUSCLE RELAXANT)| MORPHINE (PAIN) WERE ALSO BEING INFUSION| (CONCENTRATION