BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV 5 ML/H SYSTEM

    MDR report key: 1240254 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06045
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    March 30, 2007
    Report Date
    April 9, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE USED UNIT WAS RECEIVED CONTAINING NO SOLUTION. UPON RECEIPT, THE UNIT WAS VISUALLY EXAMINED FOR SIGNS OF ABNORMALITY; HOWEVER, NONE WERE FOUND. THE IMPRINT ON THE FLOW RESTRICTOR WAS NOTED TO BE CORRECT. PER PROCEDURE, A FLOW TEST WAS SUBSEQUENTLY PERFORMED ON THE UNIT FOR 43.5 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE FOLLOWING FLOW RATE (ML/HR) WAS PRODUCED FROM THE UNIT : CALCULATED 5.05 NORMALIZED (2.5%) 5.18 SPECIFICATION RANGE 4.50 ---5.50. 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 LOT 06M025 HAS BEEN CONDUCTED, WHICH REVEALED NO EVIDENCE OF RELATED DEFECTS DURING INSPECTION, TESTING AND MANUFACTURING OF THE PRODUCT LOT. 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.

    Description of Event or Problem · 1

    NATIONAL COMPLAINT COORDINATOR FOR BAXTER JAPAN REPORTED AN ALLEGED OVERINFUSION THAT OCCURRED ON ONE INFUSOR DEVICE DURING PATIENT INFUSION VIA AN INTRAVENOUS INJECTION. THE DEVICE WAS FILLED WITH 30ML OF 5-FU AND 195ML OF NORMAL SALINE FOR TOTAL FILL VOLUME OF 225ML. THE EXPECTED INFUSION TIME WAS 46 HOURS. THE ACTUAL INFUSION WAS UNKNOWN. THE DEVICE WAS NOT USED PRIOR TO THE INCIDENT. THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTION RELATED TO THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV 5 ML/H SYSTEM ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORPORATION NA 06M025

    Patients

    Seq Age Sex Outcome Treatment
    1