BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1192775 · Received October 8, 2008

    Report

    Report Number
    6000001-2008-00603
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL TECHNICIAN STATED THAT THE PUMP HAD BEEN WORKING FOR APPROX AN HOUR WHEN IT HAD A SPONTANEOUS FAILURE ON ALL 3 CHANNELS. WHEN THE PUMP STARTED TO ALARM THE KEYPAD WAS UNRESPONSIVE TO ANY BUTTONS THAT WERE PUSHED. ACCORDING TO THE EVENT HISTORY LOG THE FAILURE CODE THAT CAUSED THE ALARM WAS FAILURE CODE 500. THE PUMP IS NOW SEQUESTERED AT THE FACILITY. THE BIOMEDICAL TECHNICIAN INDICATED THAT THE RISK MANAGER MUST PROVIDE AUTHORIZATION PRIOR TO RELEASE OF THE PUMP AND RETURN TO THE PRODUCT ANALYSIS LAB (PAL) FOR EVAL. THE RISK MANAGER DECLINES TO RETURN THE DEVICE FOR EVAL PER ORGANIZATION POLICY. THE EVENT HISTORY WILL BE DOWNLOADED AND A COPY RETURNED TO THE PRODUCT ANALYSIS LAB (PAL) FOR EVAL. AN ON-SITE VISIT WAS OFFERED TO EVALUATE THE DEVICE AT THE FACILITY.

    Description of Event or Problem · 1

    THE RN MANAGER OF RECOVERY ROOM ANESTHESIA CONTACTED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A COLLEAGUE TRIPLE CHANNEL PUMP WITH THE GUARDIAN SOFTWARE THAT FAILED (THE PUMP SCREEN READ, "PUMP FAILURE") DURING AN OPEN-HEART PROCEDURE RESULTING IN BLOOD PRESSURE FLUCTUATION. THE PUMP WAS INFUSING LEVOPHED 4MG/250CC, DOBUTAMINE 500MG/250CC, AND INSULIN DRIP 100 UNITS IN 100CC AT 5 UNITS PER HOUR. THE PUMP HAD BEEN WORKING FOR AN HOUR PRIOR TO ALARMING. THE PUMP WAS UNRESPONSIVE TO ALL COMMANDS AFTER ALL THREE CHANNELS BEGAN TO ALARM. THE PUMP WAS CHANGED OUT, THE PROCEDURE CONTINUED AND COMPLETED. THE PT WAS WITHOUT MEDICATION FOR APPROX 5 MINUTES. THE ANESTHESIOLOGIST DID ADMINISTER MEDICATION TO SUSTAIN BLOOD PRESSURE WHILE THE PUMP WAS BEING SWAPPED OUT. INFO WAS NOT GIVEN AS TO THE MEDICATION THE ANESTHESIOLOGIST ADMINISTERED. THE PUMP IS CURRENTLY SECURED IN THE BIOMEDICAL DEPARTMENT AT THE FACILITY. THE STATUS IS REPORTEDLY GOOD AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention