BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240247 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06291
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 13, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    2005-047-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A FAILURE WAS INITIALLY REPORTED BY THE FACILITY AND OCCURRED DURING BIOMED TESTING. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. FAILURE CODE 403:317:864:0000 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE UIM PCB. THE FACILITY REPORTED FAILURE WAS CONFIRMED AS FAILURE CODE 403:317:864:000. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE UIM PCB BEING DEFECTIVE. THE UIM PCB WAS REPLACED.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1