BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV10 SYSTEM

    MDR report key: 1200850 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-00251
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 5, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED 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 03, 2007. THE FACILITY PHARMACIST INDICATED THAT THE ACTUAL DEVICE INVOLVED WAS DISCARDED. THUS, A COMPANION SAMPLE WAS REQUESTED. THE COMPANION SAMPLE WAS RECEIVED BY THE MANUFACTURING FACILITY, BUT IT HAS NOT BEEN EVALUATED. UPON COMPLETION, THE EVALUATION RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT. A REVIEW OF ALL RECORDS RELATED TO THE MANUFACTURE OF THE PRODUCT LOT HAS BEEN REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    EALUATION SUMMARY: ONE USED UNIT WAS RECEIVED CONTAINING 196ML OF SOLUTION INSIDE THE BLADDER. UPON RECEIPT, THE UNIT WAS VISUALLY EXAMINED FOR SIGNS OF ABNORMALITY THAT MAY HAVE CONTRIBUTED TO THE REPORTED OVERINFUSION INCIDENT; HOWEVER, NONE WERE FOUND. THE IMPRINT ON THE FLOW RESTRICTOR WAS NOTED TO BE CORRECT. SUBSEQUENTLY, PER PROCEDURE, A FLOW TEST WAS PERFORMED ON THE UNIT FOR 21.5 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE FOLLOWING FLOW RATE (ML/HR) WAS PRODUCED FROM THE UNIT: CALCULATED NORMALIZED (2.5%) SPECIFICATION RANGE 9.77 10.01 9.00 --- 10.10 THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE. THEREFORE, BASED ON THE EVALUATION FINDINGS, THE DEVICE PERFORMED AS EXPECTED. A REVIEW OF ALL RECORDS RELATED TO THE MANUFACTURE OF THE PRODUCT LOT HAS BEEN CONDUCTED, WHICH REVEALED THAT THE LOT IN QUESTION MET RELEASE CRITERIA. CONTINUED ON PAGE 3 ADDENDUM CONTINUED. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT HANDLING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR INCIDENTS FOR POSSIBLE TRENDS. CORRECTION: BASED ON THE SAMPLE EVALUATION RECEIVED FROM THE MANUFACTURING FACILITY, THE ACTUAL SAMPLE, AND NOT THE COMPANION SAMPLE, WAS RECEIVED.

    Description of Event or Problem · 1

    A FACILITY PHARMACIST ALLEGED AN OCCURRENCE OF OVERINFUSION ON A DEVICE DURING PATIENT USE. THE DEVICE WAS FILLED WITH 220ML OF 5-FU AND 5% DEXTROSE. INFUSION ON THE PATIENT WITH COLORECTAL CANCER BEGAN IN LATE 2006 AT 3PM. THE EXPECTED INFUSION TIME WAS FOR 22HOURS. ON THE NEXT DAY AT 7AM, THE NURSE DISCOVERED THAT THE DEVICE WAS EMPTY. THE PHARMACIST INDICATED THAT THE DEVICE COULD HAVE EMPTIED AS EARLY AS 14 HOURS AFTER THE START OF INFUSION. ON THE SAME DATE, IT WAS REPORTED THAT THE PATIENT HAD CHANGES IN HIS MENTAL STATE AND HAD SLURRED SPEECH. THE PATIENT WAS REPORTED TO HAVE BEEN HOSPITALIZED AND WAS RELEASED FOR HOME ON THE SAME DAY. ACCORDING TO THE PHARMACIST, THE DEVICE WAS TAKEN HOME BY THE PATIENT. IT WAS UNKNOWN WHETHER THE DEVICE WAS EXPOSED TO ANY HEAT SOURCE. LIKEWISE, THE POSITION OF DEVICE WITH RESPECT TO THE FLOW RESTRICTOR WAS UNKNOWN. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV10 SYSTEM ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORPORATION NA 06E020

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR