BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1231498 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05688
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    March 12, 2007
    Report Date
    March 21, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: FAILURE CODE 538:320:844:0000 WAS INITIALLY REPORTED BY THE FACILITY. IT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME THE INITIAL REPORT WAS RECEIVED BY BAXTER. 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..EVALUATION SUMMARY: THE DEVICE WAS EVALUATED ON 03/21/2007. THE UNINTENDED SHUTDOWN OF THE PUMP WAS CONFIRMED AND ATTRIBUTED TO A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. FAILURE CODE 538:320:844:000 WAS FOUND IN THE EVENT HISTORY AND WAS CAUSED BY THE DEFECTIVE USER INTERFACE MODULE. THE DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    A COLLEAGUE PUMP WAS RETURNED FOR SERVICE. DURING REPAIR, PAPERWORK FROM THE FACILITY WAS ENCOUNTERED THAT NOTED AN UNINTENDED SHUTDOWN OF THE INFUSION PUMP THAT OCCURRED AFTER 20 HOURS OF PATIENT INFUSION WHILE BEING ADMINISTERED DEXTROSE WITH 1/2 NORMAL SALINE. THE HOSPITAL REPRESENTATIVE STATED THAT NO PATIENT INJURY HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION 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. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1