BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2231474 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22078
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP THAT KEEPS ALARMING WAS NOT CONFIRMED NOR REPRODUCED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THE REPORTED CONDITION AND NO REPAIR WAS NECESSARY. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING ONE EXCEPTION DURING MANUFACTURING, HOWEVER, THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. DURING PREVIOUS SERVICE, THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. 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 THAT KEEPS ALARMING. ACCORDING TO THE FACILITY, THIS EVENT OCCURRED UPON POWER UP. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. 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