BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER COLLEAGUE 3 CX

    MDR report key: 2072722 · Received April 25, 2011

    Report

    Report Number
    MW5020408
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXTER MODEL "COLLEAGUE 3 CX" TRIPLE IV PUMP (B)(4) WAS SET FOR AMIODARONE INFUSION AT 30 ML - 1MG/MIN INFUSION AND VERIFIED BY 2 RNS. ONE HOUR LATER, NURSING STAFF FOUND ENTIRE IV DRIP CONTENT (500 MG AMIODARONE IN 250 ML D5W) EMPTY AND INFUSED. IV PUMP WAS FOUND CONTINUED TO BE SET AT 30 ML - 1 MG/MIN AND PUMP STATES 217 ML REMAINING BUT BAG WAS EMPTY. IV TUBING WAS FOUND RELEASED FROM IV PUMP WITHOUT ANY ALARM. FAMILY, PHYSICIAN AND PATIENT WERE NOTIFIED OF EVENT. PATIENT EXPERIENCED SOME BRADYCARDIA NOW RESOLVED; PATIENT'S HEART RATE WAS IN THE 60S AND SBP IN THE 130S. PATIENT WAS PLACED UNDER 3-1 NURSING FOR CLOSER MONITORING ON CARDIAC UNIT AND WAS EVALUATED BY CARDIOLOGIST. HEART RATE INITIALLY WAS LABILE BUT IMPROVED THE NEXT DAY WITHOUT FURTHER SIGNIFICANT EVENTS. AMIODARONE DRIP WAS DISCONTINUED AND PATIENT'S ATRIAL FIBRILLATION/FLUTTER WAS CONTROLLED WITH DILTIAZEM DRIP. PATIENT WAS PLACED UNDER 3-1 NURSING FOR CLOSER MONITORING ON CARDIAC UNIT AND WAS EVALUATED BY CARDIOLOGIST. HEART RATE INITIALLY WAS LABILE BUT IMPROVED THE NEXT DAY WITHOUT FURTHER SIGNIFICANT EVENTS. AMIODARONE DRIP WAS DISCONTINUED AND PATIENT'S ATRIAL FIBRILLATION/FLUTTER WAS CONTROLLED WITH DILTIAZEM DRIP. PUMP USED 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER COLLEAGUE 3 CX COLLEAGUE 3 CX FRN BAXTER HEALTHCARE CORP. COLLEAGUE 3 CX #12070060TC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization