BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1192684 · Received October 8, 2008

    Report

    Report Number
    6000001-2008-00602
    Event Type
    Death
    Date Received
    October 8, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE VISIT HAS BEEN OFFERED TO THE FACILITY AND ACCEPTED BY THE RISK MANAGER. A DATE AND TIME HAS NOT YET BEEN DETERMINED. THE EVENT HISTORY WILL BE FAXED TO BAXTER FOR REVIEW BY THE PRODUCT ANALYSIS LAB (PAL). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON SEPTEMBER 24, 2008 THE BAXTER FIELD SERVICE ENGINEER REPORTED A COLLEAGUE TRIPLE CHANNEL INFUSION PUMP THAT FAILED DURING PT USE WITH FAILURE CODE 812:05 ON A CRITICALLY ILL PT THAT WAS HEMODYNAMICALLY UNSTABLE. THE FAILURE CAUSED AN INTERRUPTION OF PT CARE THAT RESULTED IN HYPOTENSION AND DECREASED PERFUSION. THIS WAS A MALE WITH AN ADMITTING DIAGNOSIS OF CRUSHING CHEST INJURIES THAT OCCURRED FROM A TRACTOR THAT HAD ROLLED OVER ON HIM (DATE UNK). THE COLLEAGUE TRIPLE CHANNEL PUMP WAS INFUSING NOREPINEPHRINE AND EPINEPHRINE (DOSE, RATE, VOLUME AND CONCENTRATION UNK) WHEN ALL THREE CHANNELS ALARMED WITH FAILURE CODE 812:05 AND THE DEVICE SHUT DOWN RESULTING IN A DROP IN BLOOD PRESSURE (LEVEL UNK). THE PT EXPIRED ON AN UNK DATE DUE TO THE INJURIES SUSTAINED AT THE TIME OF THE ACCIDENT. THE RISK MANAGER INDICATED SHE FELT THAT THE PUMP FAILURE MIGHT HAVE CONTRIBUTED TO THE PT'S DEATH. BAXTER TUBING WAS IN USE AT THE TIME OF THE EVENT, HOWEVER, THE TUBING WAS DISCARDED AND THE PRODUCT CODE AND LOT NUMBER ARE UNK. AN ON-SITE VISIT WAS OFFERED AND AGREED TO BY THE RISK MANAGER. THIS IS THE FIRST OF TWO EVENTS, WHICH OCCURRED ON THE SAME PT ON DIFFERENT DATES AND WITH DIFFERENT COLLEAGUE TRIPLE CHANNEL PUMPS. THIS COMPLAINT IS LINKED TO ANOTHER COMPLAINT WHICH WAS THE FIRST EVENT.

    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 54 YR Death