BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1032753 · Received April 24, 2008

    Report

    Report Number
    6000001-2007-04405
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    February 12, 2007
    Report Date
    February 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 FEB 14 2007.EVALUATION SUMMARY:THE DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS FOUND DURING TESTING. INSPECTION OF THE DEVICE FOUND FAILURE CODE 703 IN THE EVENT HISTORY WHICH CONFIRMED THE DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. THE USER INTERFACE MODULE WAS SUBSEQUENTLY REPLACED.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER TECHNICAL SERVICE, THE INFUSION PUMP WAS FOUND TO CONTAIN A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1