BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2231415 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22059
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 15, 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 512:320 WAS NEITHER CONFIRMED OR REPRODUCED BY A BAXTER TECHNICIAN. HOWEVER, DURING THE DEVICE EVALUATION, FAILURE CODE 512:320:654:0000 WAS CONFIRMED AND REPRODUCED. THIS CONDITION WAS CAUSED BY A DEFECTIVE USER INTERFACE MODULE (UIM) PRINTED CIRCUIT BOARD (PCB). THE UIM PCB WAS REPLACED TO CORRECT THIS CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND. A SERVICE HISTORY REVIEW WAS ALSO 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 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 512:320. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THE FACILITY DID NOT HAVE INFORMATION REGARDING PATIENT INVOLVEMENT OR WHETHER THERE HAVE BEEN ANY REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT, AND THIS FACILITY WAS NOT WILLING TO BE CONTACTED FOR ANY FURTHER INFORMATION. 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