BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2233504 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22436
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INVOLVED AN UNREMEDIATED INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 7:01:00. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION, AS THE ONLY RECORDS AVAILABLE ARE FOR PREPARATION AND INSTALLATION. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE. EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 810:15 WAS CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS ASSIGNED TO MOISURE ON THE PUMP HEAD MODULE TUBING. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE WAS RETURNED TO BAXTER IRELAND 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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED, TO BAXTER (B)(4), A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:15. THIS EVENT OCCURRED AFTER THE CUSTOMER TRIED REMOVING AND RELOADING THE SET. IT IS UNKNOWN IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. ACCORDING TO THE FACILITY REPRESENTATIVE, THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    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