BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1893802 · Received November 9, 2010

    Report

    Report Number
    6000001-2010-04781
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER (B)(4) FOR EVALUATION. THE EVALUATION RESULTS INDICATE: THE SELF TEST ON AC POWER PASSED. CHANNEL C IN COLLEAGUE GUARDIAN MODE WAS INFUSING (B)(4) ON PRIMARY AT 33.0ML/HOUR, CHANNEL B IN COLLEAGUE GUARDIAN MODE WAS INFUSING FENTANYL ON PRIMARY AT 110ML/HOUR AND CHANNEL A WAS INFUSING ON PRIMARY AT 250ML/HOUR WITH PIGGYBACK RATE OF 125ML/HOUR (NON-INFUSING). THE PUMP SHOWED TWO DIFFERENT RATES DUE TO PIGGYBACK WITH RATE 125ML/HOUR WAS ACCESSED ON THE MAIN SCREEN WHILE THE PUMP WAS INFUSING ON PRIMARY WITH THE RATE OF 250ML/HOUR. THIS INDICATES THAT THE PUMP WAS FUNCTIONING AS PROGRAMMED. THE PUMP INFUSED WITHOUT ALARM OR MALFUNCTIONS. CHANNEL A WAS MONITORED FOR ANY RATE CHANGE ON THE MAIN AND NO PROBLEM FOUND. THE KEYPAD AND PANEL LOCKOUT SWITCH TEST WAS PERFORMED AND PASSED. TRACES OF FLUID INTRUSION WERE FOUND ON THE CENTER HOUSING, BOTTOM PANEL & SUB PLATE. THE REPORTED PROBLEM WAS DUPLICATED AND CONFIRMED. THE SOFTWARE VERSION IN THIS PUMP IS: MASTER 6.13.92, SLAVE 4.03.00 AND PHM 2.07.00. A LABELING REVIEW WAS PERFORMED WHICH DETERMINED THE CUSTOMER HAD MISTAKENLY THOUGHT THERE WAS AN ERROR WITH THE PUMP WHEN THE MAIN DISPLAY HAD SHOWN A DIFFERENT VALUATE FROM WHAT THE PUMP HEAD MODULE HAD SHOWN. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON OCT 15 2010, A CUSTOMER REPORTED THAT THE COLLEAGUE VOLUMETRIC INFUSION PUMP ENCOUNTERED AN EVENT WHERE THERE WAS A PATIENT INVOLVED. THE EVENT IS NOT CLEAR; HOWEVER, THE CUSTOMER HAS STATED THAT THIS WAS AN 'OCCURRENCE' (DEFINED AS AN UNEXPECTED OR UNDESIRABLE THAT IS NOTEWORTHY BY VIRTUE OF THE HAZARD, IT CREATES OR OF THE HARM IT CAUSES OR CAN CAUSE PATIENT, RESIDENCES, CLIENTS, OTHERS ASSOCIATED WITH THE REGION AND/OR EQUIPMENT OR PROPERTY). THE DEGREE OF INJURY IS UNKNOWN. THE PUMP WAS SET AT 250 ML/HR ON CHANNEL A AS PER THE MAIN SCREEN, BUT THE PUMP HEAD MODULE (PHM) SCREEN READ 125 ML/HR. THE PATIENT BECAME HYPOTENSIVE. INFUSION STARTED AT 1000 HRS AND THE EVENT WAS NOTICED AT 1300 HRS. THE FACILITY'S BIOMED WAS UNABLE TO DUPLICATE THE PROBLEM AND NO ERRORS OR FAILURES WERE LOGGED. A COMPLETE INSPECTION WAS PERFORMED AND EVERYTHING IS FUNCTIONING TO MANUFACTURER'S SPECIFICATIONS. ADDITIONAL INFORMATION RECEIVED FROM THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2010 IS AS FOLLOWS: MAINTENANCE INTRAVENOUS FLUIDS WERE RUNNING. THE PATIENT DID BECOME HYPOTENSIVE AND DID REQUIRE A FLUID BOLUS TO CORRECT THIS. THE PATIENT RECOVERED. THIS PUMP WAS SENT TO BAXTER FOR EVALUATION. THE SOFTWARE VERSION OF THIS PUMP IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention