BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1981121 · Received February 8, 2011

    Report

    Report Number
    6000001-2011-00727
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WHICH OVER-INFUSED WAS NOT CONFIRMED OR DUPLICATED DURING PRODUCT EVALUATION. THE DEVICE MET SPECIFICATIONS IN RELATION TO THE REPORTED CONDITION. A VISUAL INSPECTION AND DELIVERY ACCURACY TESTS WERE PERFORMED AND FOUND THE PUMP TO BE DELIVERING WITHIN SPECIFICATIONS. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THE REPORTED CONDITION AND NO REPAIR WAS NECESSARY. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00. A SERVICE HISTORY REVIEW REVEALED THIS DEVICE HAS NOT BEEN SERVICED BY BAXTER PRIOR TO THIS EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTIONS DURING MANUFACTURING. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. 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 THAT OVER-INFUSED. THIS EVENT OCCURRED IN THE PEDIATRICS UNIT DURING DELIVERY ON A PATIENT. THE RATES AT WHICH THE DEVICE WAS INFUSING AND THE DRUG ARE BOTH UNKNOWN. ACCORDING TO THE FACILITY, "CHANNEL C FINISHED TOO SOON." THERE WAS NO REPORT 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 PUMP IS CURRENTLY UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1