BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1992140 · Received February 15, 2011

    Report

    Report Number
    6000001-2011-01010
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH "CHANNEL 1 HAVING A LOT OF PROBLEMS" WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. 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 WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH "CHANNEL 1 HAVING A LOT OF PROBLEMS." ACCORDING TO THE FACILITY, THIS EVENT OCCURRED DURING PATIENT USE IN THE INTENSIVE CARE UNIT AND INTERRUPTED DELIVERY. THERE WAS NO 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 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DRUG