BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2042563 · Received April 6, 2011

    Report

    Report Number
    6000001-2011-02607
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 810:03 WAS CONFIRMED BUT NOT REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE AN AIR IN LINE (AIL) BOARD FAILURE. THE AIL PRINTED CIRCUIT BOARD WAS REPLACED IN CHANNEL B IN ORDER TO FIX THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED AN 810:03 FAILURE CODE. DURING REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER SERVICE PERSONNEL, THIS FAILURE CODE WAS FOUND TO HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, AND THEREFORE NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1