BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 571690 · Received February 7, 2005

    Report

    Report Number
    6000001-2005-00254
    Event Type
    Injury
    Date Received
    February 7, 2005
    Date of Event
    January 10, 2005
    Report Date
    February 7, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT REPORTED AN INFUSION PUMP WITH A FAILURE CODE 12:303:984:0002. THE PUMP WAS REPORTED TO BE USED ON AN OPEN HEART UNIT PT WHEN THE FAILURE OCCURRED. THE NURSE DISCOVERED THE PUMP WAS DISPLAYING THE FAILURE AND REPORTEDLY, THE PT'S VITALS WERE COMPROMISED. THE PT REQUIRED ANESTHESIA TO ADMINISTER MEDICATION AND TO STABILIZE THE PT, HOWEVER, NO INJURY RESULTED FROM THE EVENT. DESPITE BAXTER'S EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PT'S DEMOGRAPHICS AND DIAGNOSIS, MEDICATION INVOLVED, TYPE OF MEDICAL INTERVENTION REQUIRED, PT'S VITAL SIGNS PRIOR AND DURING THE EVENT, OR SET UP OF THE PUMP. NO ADDITIONAL CONTACT INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention