BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 483028 · Received September 13, 2002

    Report

    Report Number
    6000001-2002-03387
    Event Type
    Malfunction
    Date Received
    September 13, 2002
    Date of Event
    August 29, 2002
    Report Date
    August 29, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL ENGINEER REPORTED AN INFUSION PUMP WITH AN 812:02 FAILURE CODE IN CHANNEL B TO BAXTER CUSTOMER SERVICE THAT WAS FOUND DURING BIOMED TESTING. THE BIOMED STATED THAT THERE HAVE BEEN NO REPORTS 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 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) COLLEAGUE 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN