BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2385667 · Received December 22, 2011

    Report

    Report Number
    6000001-2011-41902
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    November 27, 2011
    Report Date
    November 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. THE REPORTED PROBLEM WAS CONFIRMED VIA THE EVENT HISTORY LOG REVIEW. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 5.09.90. 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 REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 589:317:1061 WAS CONFIRMED DURING PRODUCT EVALUATION BY BAXTER SERVICE PERSONNEL. THIS CONDITION WAS ATTRIBUTED TO FAULTY MAIN BATTERIES AS A RESULT OF USER ERROR. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS BEEN SERVICED TEN TIMES PRIOR TO THIS EVENT. THE DEVICE HAS BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "FAILURE CODE 589:317:106". A DEVICE HISTORY RECORD REVIEW WAS ALSO PERFORMED FINDING NO ABNORMALITIES.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP MALFUNCTION WITH FAILURE CODE 589:317:1061. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE USER INTERFACE MODULE SOFTWARE VERSION FOR THIS DEVICE IS UNKNOWN AT THIS TIME. THE CUSTOMER IS WILLING TO BE CONTACTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1