BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2191463 · Received August 4, 2011

    Report

    Report Number
    6000001-2011-16539
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    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). THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA. DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP THAT EXPERIENCED FAILURE CODE 810:11 WAS CONFIRMED DURING PRODUCT EVALUATION IN THE PUMP'S EVENT HISTORY. THIS CONDITION WAS CAUSED BY AN OUT OF CALIBRATION AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB). THE AIL PCB WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP THAT EXPERIENCED FAILURE CODE 810:11. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND IN THE GENERAL PT WARD UPON PROGRAMMING/SETUP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    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