BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1083310 · Received July 28, 2008

    Report

    Report Number
    6000001-2008-00440
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE VISIT HAS BEEN SCHEDULED TO MEET WITH THE STAFF INVOLVED IN THE INCIDENT TO GATHER AS MUCH INFO AS POSSIBLE ABOUT THE EVENT AND COMPLETE AN INITIAL VISUAL INSPECTION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN 2008, BAXTER REC'D A REPORT THAT A COLLEAGUE TRIPLE CHANNEL PUMP CAUGHT FIRE ON THE SAME DAY, WHILE IN STORAGE AND RESULTED IN FOUR STAFF MEMBERS BEING EXPOSED TO THE FUMES. THE CHARGE NURSE REPORTED THAT AN IV INFUSION PUMP (COLLEAGUE-3) WAS DISCOVERED ABLAZE AND THE INTERNAL BATTERY WAS LEAKING FLUID. THE PUMP WAS LOCATED IN THE OPERATING ROOM IV PUMP ROOM. STAFF HAD EXTINGUISHED THE FIRE AND CONTAINED THE PUMP PRIOR TO THE REPORTING. NO OTHER OBJECTS OR PERSONS WERE BURNED, BUT FOUR STAFF PERSONS WERE EXPOSED TO THE FUMES AND EXPERIENCED SUBSEQUENT RESPIRATORY AND EYE IRRITATION. TWO OF THE FOUR STAFF PERSONS ELECTED TO BE TREATED IN THE ER, THE OTHER TWO REFUSED ER TREATMENT. THIS COMPLAINT IS RELATED TO MASTER COMPLAINT. THIS COMPLAINT INVOLVES THE EVENT ASSOCIATED WITH EMPLOYEE, A MALE, WHO REFUSED TO GO TO THE EMERGENCY ROOM. HE IS REPORTEDLY DOING WELL.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening