BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1159830 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-01515
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    October 18, 2006
    Report Date
    October 18, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 16 2007. EVALUATION SUMMARY:THE CONDITION OF INACCURACY WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS WAS CAUSED BY A FAULTY PUMP HEAD MODULE THAT WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE TESTING, THE BAXTER REPAIR TECHNICIAN REPORTED THAT THE DEVICE WAS INACCURATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1