BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1193082 · Received October 13, 2008

    Report

    Report Number
    6000001-2007-04370
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    January 29, 2007
    Report Date
    January 29, 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, US
    Reporter Occupation
    OTHER

    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 FEB 13, 2007. EVALUATION SUMMARY: EVALUATION WAS PERFORMED AND THE CONDITION OF DEFECTIVE UIM PCB WAS CONFIRMED. INSPECTION OF THE PUMP REVEALED DEFECTIVE USER INTERFACE MODULE PRINTER CIRCUIT BOARD (UIM PCB) CAUSED FAILURE CODE 703:00. THE UIM PCB WAS REPLACED. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, DEFECTIVE USER INTERFACE MODULE PRINTER CIRCUIT BOARD (UIM PCB) WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1