BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1205467 · Received October 22, 2008

    Report

    Report Number
    6000001-2007-04557
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    January 6, 2007
    Report Date
    January 24, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA FEBRUARY 21, 2007. EVALUATION SUMMARY: EVALUATION OF THE DEVICE WAS COMPLETED BY THE BAXTER REPAIR TECHNICIAN. THE CUSTOMER REPORTED FAILURE CODE 313 ON CHANNEL C WAS CONFIRMED IN THE EVENT HISTORY HOWEVER COULD NOT BE DUPLICATED. INSPECTION OF THE DEVICE REVEALED POOR GROUND MAY INTRODUCE NOISE TO THE 1HZ SIGNAL, THEREFORE IF THE SIGNAL LINE IS NOT LARGE ENOUGH TO MAKE THE 1 HZ DIFFERENT SIGNAL CAUSING THE FAILURE CODE 313 TO MANIFEST. THE UIM PCB WAS REPLACED AND THE DEVICE WAS TESTED BY THE REPAIR TECHNICIAN.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 313:425:250:002 ON CHANNEL C. THE FAILURE WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE, AFTER INFUSION STARTED. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1