BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2020736 · Received March 16, 2011

    Report

    Report Number
    6000001-2011-01899
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    September 22, 2010
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 703:00 WAS CONFIRMED DURING PRODUCT EVALUATION. HOWEVER, THIS CONDITION COULD NOT BE REPRODUCED. AN ASSIGNABLE ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN DISCOVERED A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 703:00. THIS PROBLEM WAS IDENTIFIED DURING SERVICE AND INTERRUPTED DELIVERY AS THE PUMP WAS BEING TESTED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.03.00.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1