BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1852300 · Received October 4, 2010

    Report

    Report Number
    6000001-2010-03719
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER, A BAXTER FIELD SERVICE TECHNICIAN PERFORMED DEVICE EVALUATION AT THE CUSTOMER LOCATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A BATTERY DEPLETED SET ALARM, AND THE ROOT CAUSE WAS DETERMINED TO BE A DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4), A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A BATTERY DEPLETED SET ALARM WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.06.00, WHICH IS CLASSIFIED AS UNREMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1