BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2427032 · Received January 25, 2012

    Report

    Report Number
    6000001-2012-04353
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    November 30, 2011
    Report Date
    December 27, 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 589:317:1061:0000 WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006.

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION BY QUALITY ENGINEERING, IT WAS DETERMINED THAT THERE IS NO INFORMATION TO SUGGEST THAT THIS DEVICE MALFUNCTION WOULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 589:317:1061:0000. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION NEEDED 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