BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230904 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22016
    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
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. 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 REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH DAMAGED BATTERY WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO CORRECT THE REPORTED CONDITION. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. 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