BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2221085 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20467
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS NOT SENT TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP THAT INFUSED 12 HOURS WORTH OF MEDICATION IN 6 HOURS CANNOT BE CONFIRMED NOR CAN AN ASSIGNABLE CAUSE BE PROVIDED. SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF "THE PUMP INFUSED 12 HOURS WORTH OF MEDICATION IN 6 HOURS. THE OCCURRED DURING PATIENT USE IN THE MEDICAL SURGERY DEPARTMENT. THERE WERE NO REPORTS OF 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 DEVICE 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