BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER

    MDR report key: 2011493 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01709
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(4), 2011 AND NOT THE ORIGINALLY REPORTED OCCURRENCE DATE OF (B)(4), 2011. DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER, A BAXTER FIELD SERVICE TECHNICIAN REPAIRED THIS DEVICE AT THE CUSTOMER SITE. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A BATTERY ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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). THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.92. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE DEVICE, PRODUCT CODE DNM9161L, SN (B)(4), FOR BATTERY ISSUE. PATIENT INJURY WAS NOT REPORTED. THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON SITE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CANADIAN TECHNICAL SERVICES. INCIDENT DATE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1