BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 511482 · Received February 10, 2004

    Report

    Report Number
    6000001-2004-00155
    Event Type
    Death
    Date Received
    February 10, 2004
    Date of Event
    December 13, 2003
    Report Date
    January 12, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED VIA USER FACILITY REPORT THE DEATH OF A PT. THE EVENT DESCRIPTION STATED "100 CC'S OF INTEGRILLIN TO BE INFUSED AT 5.5 CC PER HOUR INFUSED OVER A 10 MINUTE PERIOD". THE FACILITY'S RISK MGR REPORTED THE PT WAS BEING PREPARED FOR A TRANSPORT FROM THE E.R. TO THE I.C.U.. A TRIPLE CHANNEL PUMP WAS INFUSING NITROGLYCERIN AND HEPARIN ON CHANNEL A AND B AND INTEGRILLIN ON CHANNEL C. THE RISK MGR STATED THAT A BAG OF SALINE WAS ALSO CONNECTED TO THE PT, AS A MAINTENANCE FLUID, AND WAS BEING USED FOR FLUSHES. THE SALINE LINE WAS CLAMPED AND WAS NOT ON A PUMP. REPORTEDLY, WHEN INTEGRILLIN BAG WAS CHANGED, "THE NURSE CHOSE THE WRONG LINE" AND PLACED INTEGRILLIN BAG ON THE SALINE LINE, WHICH SHE UNCLAMPED. AS A RESULT, INTEGRILLIN FREE FLOWED. AFTER THE EVENT, THE PT'S HEART RATE AND OXYGEN SATURATION DECREASED. A CT SCAN OF THE PT'S BRAIN SHOWED DIFFUSE INTRACEREBRAL BLEEDING. THE PT WAS TRANSPORTED TO THE I.C.U. AND INTUBATED. THE PT EXPIRED TWO DAYS LATER. ACCORDING TO THE RISK MGR, AN AUTOPSY WAS NOT PERFORMED AND THE FACILITY DID NOT KNOW WHETHER OR NOT THE PT'S DEATH WAS RELATED TO THE REPORTED EVENT. THE FACILITY DID NOT KNOW WHETHER OR NOT THE INTRACEREBRAL BLEEDING WAS RELATED TO THE OVERINFUSION OF INTEGRILLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death