BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2240360 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23507
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. 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). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP THAT EXPERIENCED A DAMAGED BATTERY ALARM WAS CONFIRMED AND REPRODUCED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS DETERMINED TO BE DAMAGED BATTERIES RESULTING FROM USE/USER ERROR. THIS CONDITION WAS RESOLVED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN BY REPLACING THE BATTERIES AND BATTERY HARNESS. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.92 WHICH IS CATEGORIZED AS A COLLEAGUE P1.5. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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