BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 551549 · Received October 25, 2004

    Report

    Report Number
    6000001-2004-01631
    Event Type
    Death
    Date Received
    October 25, 2004
    Date of Event
    September 10, 2004
    Report Date
    September 28, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL'S RISK MANAGEMENT DEPT. REPORTED AN INCIDENT WHERE A PT INADVERTENTLY RECEIVED A WHOLE BOTTLE OF PROPOFOL. PROPOFOL WAS INFUSING ON A COLLEAGUE INFUSION PUMP TO A CRITICALLY ILL "CARDIAC" PT. THE PROPOFOL DRIP WAS REPORTED TO BE TITRATED TO THE PT'S RESPONSE. THE PT WAS IN A "CODE INTUBATION" AND THE CLINICAL STAFF WAS EXPERIENCING DIFFICULTY INTUBATING THE PT. THE CODE WAS REPORTED TO LAST APPROXIMATELY 40 MINUTES. DURING THE CODE, "ANESTHESIA CAME AND WANTED TO GIVE THE PT A BOLUS OF PROPOFOL VIA SYRINGE." REPORTELY, THE TUBING WAS TAKEN OUT OF THE PUMP TO FILL THE SYRINGE FOR BOLUS. AT THAT TIME, THE FREE-FLOW PROTECTION CLAMP WAS CLOSED ON THE TUBING WHICH WAS THEN OPENED UP BY THE USER. AFTER THE SYRINGE WAS FILLED, THE TUBING WAS NOT CLAMPED BACK AND WAS NOT PUT BACK ON THE PUMP AND THE PT INADVERTENTLY RECEIVED THE WHOLE BOTTLE OF MEDICATION. THE PT'S BLOOD PRESSURE DROPPED "INTO THE 60'S" REQUIRING NEO-SYNEPHRINE ADMINSTRATION FOR PRESSOR SUPPORT. THE PT'S BLOOD PRESSURE INCREASED TO THE 130S WITHIN 15 MINUTES AND THE PT WAS WEANED OFF NEO-SYNEPHRINE. ACCORDING TO THE RISK MANAGER, THE PT RECOVERED FROM THE INCIDENT. THE PT WAS "VENTED" AND WAS PUT BACK ON THE PROPOFOL DRIP. THE FAMILY MADE DECISION TO WITHDRAW LIFE SUPPORT DUE TO PT'S MEDICAL HISTORY AND UNCONSCIOUS STATE AND TO APPLY ONLY COMFORT MEASURES. THE PT WAS ALLOWED TO EXPIRE THE SAME DAY. THE RISK MANAGER STATED THE INCIDENT HAD BEEN REVIEWED BY THE HOSPITAL AND THE HOSPITAL DID NOT BELIEVE THE VENT HAD CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THE RISK MANAGER REPORTED THAT THE CAUSE OF THE PT'S DEATH WAS DETERMINED TO BE MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE, AND HIGH CHOLESTEROL. DESPITE BAXTER'S EFFORTS TO OBTAIN ADD'L INFO FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PT'S DEMOGRAPHICS, RATE AND CONCENTRATION OF PROPOFOL, SERIAL NUMBER OF THE PUMP, AND SET UP OF THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death BAXTER IV SOLUTION SET (PRODUCT CODE 1C8109S).