BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240109 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06125
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 10, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE.LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DURING PRODUCT EVALUATION, REPORTED CONDITION OF WILL NOT TURN ON AND PROBLEMS WITH LOAD TUBING WAS CONFIRMED. THE PUMP WAS RECEIVED WITH CHANNEL A AND CHANNEL B OPEN. THE PUMP WILL NOT POWER ON WITH AN OPEN CHANNEL. FAILURE CODE 715:00 ON CHANNEL A WAS FOUND IN THE EVENT HISTORY. FAILURE CODE 715:00 HAVE KNOWN TO OCCUR WHEN THE MANUAL TUBE RELEASE IS TIMED-OUT OR USED IMPROPERLY MULTIPLE TIMES. CHANNEL A AND CHANNEL B WERE RESET USING MANUAL TUBE RELEASE KNOBS. THE PUMP PASSED POWER ON SELF-TEST ON AC AND BATTERIES WITHOUT ANY FAILURE. DURING EVALUATION FROM THE EVENT HISTORY IT WAS CONFIRMED THAT THIS FAILURE WAS NOT OCCURRED DURING INFUSION. 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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP THAT WILL NOT TURN ON AND HAS TUBE LOADING PROBLEMS. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. 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 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE.LTD. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1