BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    MDR report key: 2025185 · Received March 21, 2011

    Report

    Report Number
    6000001-2011-02031
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-3/15/05-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A 810:11 FAILURE CODE WAS CONFIRMED DURING REVIEW OF THE EVENT HISTORY LOG. THE ASSIGNABLE CAUSE WAS A DEFECTIVE PUMP HEAD MODULE (PHM). THE PHM WAS REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: THE USER INTERFACE MODULE SOFTWARE VERSION IS 6.13.92. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. BAXTER'S INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A FAILURE CODE 810:11 WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. 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 3 CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1