BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 382479 · Received March 14, 2002

    Report

    Report Number
    6000001-2002-00213
    Event Type
    Death
    Date Received
    March 14, 2002
    Date of Event
    February 6, 2002
    Report Date
    February 13, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS A TRIPLE CHANNEL INFUSION PUMP WAS INFUSING NEOSYNEPHIRINE ON CH. A, PROPOFOL ON CH. B AND CH. C IN STANDBY MODE. WHEN CH. C WAS SELECTED, THE PUMP'S SCREEN WENT BLANK AND THEN DISPLAYED "FAILURE". THE PUMP WAS UN-PLUGGED AND PLUGGED BACK INTO THE WALL OUTLET AND THEN WAS TURNED BACK ON AND GAVE AN "OUT OF SERVICE" MESSAGE ON CHANNELS A&B WITH CH. C NOW FUNCTIONAL. THE NEOSYNEPHRINE AND PROPOFOL LINES WERE REMOVED BY USING THE MANUAL TUBE RELEASE ON THE PUMP AND THE INFUSION WAS RESTARTED ON A DIFFERENT PUMP. IN THE TIME THAT PASSED WHILE TRYING TO GET THE INFUSIONS RESTARTED THE PATIENT'S ICP WENT FROM THE 5-8 RANGE TO 26-28 AND THE BLOOD PRESSURE WENT FROM 90-100'S TO 200 SYSTOLIC. INITIAL INFORMATION RECEIVED FORM THE FACILITY REPORTED THAT THE PATIENT EXPIRED AFTER THIS INCIDENT DUE TO PRE-EXISTING CONDITIONS. THE MALFUNCTION OF THE PUMP WAS NOT REPORTED AS THE CAUSE OF THE DEATH. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE REPORTING FACILITY. SPECIFIC REQUESTS FOR PATIENT INFORMATION AND THE EVENTS AND TIME THAT ELAPSED BETWEEN THE REPORTED FAILURE AND THE PATIENT'S DEATH WERE NOT ANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) COLLEAGUE 3CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death