BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    MDR report key: 2071923 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03250
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    February 26, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY DEPLETED ALARM SET WAS CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS ASSIGNED TO A BATTERY DEPLETED ALARM. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING BAXTER (B)(4) REVIEW OF THE EVENT HISTORY, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED BATTERY DEPLETED ALARM SET, INTERRUPTING DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1