BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2231465 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22074
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 16, 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 FAILURE CODE 37:419 WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION BY BAXTER SERVICE PERSONNEL. THE SAMPLE EVALUATION FOUND SEVERAL COMPONENTS THAT CAUSED THE REPORTED CONDITION. THE USER INTERFACE MODULE-PRINTED CIRCUIT BOARD, SOFTWARE, AND THE USER INTERFACE/PUMP HEAD MODULE SIGNAL AND POWER HARNESS WERE ALL DEFECTIVE AND REPLACED TO CORRECT THIS CONDITION. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED SEVEN TIMES BUT NOT FOR THE FOR THE REPORTED CONDITION OF FAILURE CODE 37:419. DURING PREVIOUS SERVICES, THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER.

    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 WITH FAILURE CODE 37:419. 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. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90.

    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