BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SV 2ML/HR

    MDR report key: 1170887 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-01496
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 11, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 15 2007. A SAMPLE EVALUATION WAS NOT CONDUCTED AS THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT HAS BEEN DISCARDED BY THE REPORTING FACILITY. THE REPORTER STATED THAT THEY BELIEVE THAT THEY HAVE NOT BEEN USING THE DEVICE AS DIRECTED BECAUSE THEY HAVE BEEN UNDER-FILLING THEM. A BATCH REVIEW HAS BEEN CONDUCTED ON LOT NUMBER 06E007, WHICH REVEALED THAT THE LOT PASSED ALL RELEASE CRITERIA.THE DIRECTION INSERT PROVIDED WITH THE DEVICE STATES THAT A 10% OR GREATER INCREASE IN FLOW RATE MAY RESULT WHEN THE FILL VOLUME IS REDUCED TO 60% OR LESS OF THE NOMINAL FILL VOLUME. THE NOMINAL FILL VOLUME FOR THIS DEVICE IS 96 ML. THE FACILITY FILLED THE DEVICE WITH 40 ML OF SOLUTION. THE CUSTOMER REPORTED THAT A SALES REPRESENTATIVE FROM BAXTER WILL BE CONDUCTING A TRAINING SESSION FOR THEIR FACILITY WITH REGARDS TO USING THE INFUSOR DEVICE. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ANECDOTAL REPORT OF AN OVERINFUSION INCIDENT. IT WAS REPORTED THAT THE INFUSION WAS FASTER THAN EXPECTED. THE CUSTOMER'S EXPECTED INFUSION DURATION WAS 22 HOURS. THE TOTAL FILL VOLUME, DRUG AND DILUENT USED IS UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, THE CUSTOMER IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SV 2ML/HR ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORPORATION NA 06E007

    Patients

    Seq Age Sex Outcome Treatment
    1