BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2316274 · Received October 31, 2011

    Report

    Report Number
    6000001-2011-35260
    Event Type
    Malfunction
    Date Received
    October 31, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER PERSONNEL, 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). THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 201:422:558 WAS CONFIRMED BY BAXTER PERSONNEL IN THE PUMP'S EVENT HISTORY. THE ROOT CAUSE WAS ASSIGNED TO A FAULTY USER INTERFACE MODULE PRINTED CIRCUIT BOARD. THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED TO CORRECT THIS CONDITION. A SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS BEEN SERVICED THREE TIMES PRIOR TO THIS EVENT. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF 201:422:558. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 201:422:558. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. 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