BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER-COLLEAGUE 3CX

    MDR report key: 1057111 · Received June 3, 2008

    Report

    Report Number
    1057111
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 3, 2008
    Manufacturer
    BAXTER
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS 3 CHAMBER COLLEAGUE IV PUMP WAS NOTED TO HAVE CHAMBER 2 FAILURE SO CHAMBER 1 OR 3 WAS USED TO INFUSE THE MEDICATION. THE CHAMBER USED WAS PROGRAMMED FOR THE DRIP ACCORDING TO THE MD'S ORDER AT 5:28PM IN '08. AROUND 12:00AM IN THE NEXT DAY, THE NURSE SUPERVISOR NOTED THAT THE BAG WAS ALMOST EMPTY (APPROX. 50CC REMAINING IN THE BAG) AND SHOULD HAVE ONLY INFUSED APPROX 77 CC. ACCORDING TO THE READING ON THE PUMP 98CC HAD INFUSED. ALL TOTAL FROM 5:28PM UNTIL 12:00 MIDNIGHT THE PATIENT HAD RECEIVED ALL BUT 50CC OF A 250CC BAG OF ARGATROBAN (SHOULD HAVE LASTED 24 HRS). FYI: IT WAS ALSO NOTED THAT ANOTHER PUMP IN THE SCU HAD SIMILAR ISSUES OVER THE PAST WEEKEND AND THAT PUMP ALSO HAD A CHAMBER FAILURE (SEPARATE FORM 3500A COMPL). BOTH IV PUMPS HAVE BEEN REMOVED FROM SERVICE PENDING INVESTIGATION AND PLACED IN DQM OFFICE WITH A RED TAG. ALL OTHER BAXTER COLLEAGUE PUMPS IN THE SCU WILL BE SERVICED/ INSPECTED TO ENSURE THAT THEY ARE WORKING PROPERLY. THE VENDOR/MFR (REPRESENTATIVE) WAS CONTACTED TO INFORM THEM OF THIS EVENT. PT WAS MONITORED AND LABS BEGAN TO RETURN TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER-COLLEAGUE 3CX IV PUMP FRN BAXTER H1602MB81631M

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening