BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL

    MDR report key: 1932255 · Received December 17, 2010

    Report

    Report Number
    6000001-2010-05892
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS EVALUATED AT THE FACILITY BY A BAXTER TECHNICIAN. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF FAILURE CODE 550:121:1005:0000. THE ROOT CAUSE COULD NOT BE DETERMINED. NO REPAIRS WERE NECESSARY TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A FAILURE CODE 550:121:1005:0000. THE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR, AS THE USER PRESSED THE "NO" SOFT KEY DURING THE SPEAKER TEST ALTHOUGH NO PROBLEMS WITH THE SPEAKER WERE DISCOVERED DURING SERVICE. NO REPAIRS WERE NECESSARY TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED FAILURE CODE 550:121:1005:0000. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION, FINDING A FAILED SPEAKER TEST IN THE EVENT HISTORY, INDICATING THE DEVICE MAY HAVE FAILED TO ALARM. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS CONDITION OCCURRED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE SOFTWARE VERSION OF THIS DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1