BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1237904 · Received November 21, 2008

    Report

    Report Number
    6000001-2007-88242
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 4, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BY BAXTER QUALITY MANAGEMENT FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILLED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:EVALUATION WAS PERFORMED AND THE REPORTED CONDITION OF FAILURE CODE 4:311:3686:001D WAS NOT CONFIRMED IN THE EVENT HISTORY AND COULD NOT DUPLICATED. HOWEVER FAILURE CODE 4:311:3686:001D IS CAUSED BY THE MANIPULATION OF THE MANUAL TUBE RELEASE (MTR) KNOB. REVIEW OF THE EVENT HISTORY REVEALED CHANNEL C HAD RESET MANUAL TUBE RELEASE SET ALERTS MULTIPLE TIMES. THE CHANNEL C PUMP HEAD MODULE WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH AN FAILURE CODE 4:311:3686:001D. THIS EVENT OCCURRED DURING PATIENT INFUSION. 0.9 SODIUM CHLORIDE WAS INFUSING AT THE TIME OF THE EVENT. DURING INFUSION PUMP STOPPED AND DISPLAYED THE FAILURE CODE 4:311:3686:001D. ACCORDING TO THE HOSPITAL REPRESENTATIVES THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1