BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1920411 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05749
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 7, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS EVALUATED ONSITE AT THE FACILITY BY A BAXTER TECHNICIAN. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION OF A BATTERY ISSUE WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. A BAXTER REPAIR TECHNICIAN REPLACED THE BATTERIES AND HARNESS TO RESOLVE THIS ISSUE. 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. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (B)(4). THIS INFORMATION WAS INCORRECT IN THE INITIAL MEDWATCH. ADDITIONAL EVALUATION CODE THAT WAS NOT INCLUDED IN INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY DETERMINED A BATTERY DEPLETED SET INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE MASTER SOFTWARE VERSION OF THIS DEVICE WAS 5.80.92, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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