BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1962150 · Received January 17, 2011

    Report

    Report Number
    6000001-2011-00314
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "AIR DETECTOR PROBLEM." (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: THE REPORTED CONDITION OF CHANNEL B AIR DETECTOR PROBLEM WAS CONFIRMED IN THE EVENT HISTORY BUT WAS NOT DUPLICATED. THE AIR IN LINE ALARMS FUNCTIONED AS DESIGNED, THEREFORE NO CORRECTION IS NEEDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.03.00 CATEGORIZED AS UNREMEDIATED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER?S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER REPORTED ON BEHALF OF THE FACILITY A COLLEAGUE INFUSION PUMP WITH A REPORTED CONDITION OF "AIR DETECTOR PROBLEM." IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1