BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 471138 · Received August 27, 2002

    Report

    Report Number
    6000001-2002-02675
    Event Type
    Malfunction
    Date Received
    August 27, 2002
    Date of Event
    July 24, 2002
    Report Date
    July 29, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFUSION PUMP WITH AN 812:092 FAILURE. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER'S TECHNICIAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PATIENT STATUS, MEDICAL INTERVENTION, PATIENT INJURY, AGE OF PATIENT, MEDICATION INVOLVED OR THE SET UP OF THE INFUSION DEVICE. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN