IVENIX, INC.

Description of Event or Problem

THE FOLLOWING HAS BEEN REPORTED: ALARM- TUBING SET PROBLEM A PRELIMINARY REVIEW OF THE DEVICE LOGS WAS NOT PERFORMED. THE ADMINISTRATION SET WAS RETURNED FOR EVALUATION. THE SAMPLE WAS EVALUATED AND UNDERWENT A DETAILED 6M INVESTIGATION. VISUAL EXAMINATION IDENTIFIED A LEAK PATTERN NEAR THE SIDE CASSETTE AREA. HOWEVER, REPEAT FUNCTIONAL TESTING AND CONFIRMATION TESTING COULD NOT REPRODUCE THE REPORTED LEAK CONDITION. THE MANUFACTURING PROCESS, EQUIPMENT PARAMETERS, MATERIALS, AND METHODS WERE REVIEWED AND FOUND TO BE WITHIN VALIDATED SPECIFICATIONS. EXTENDED PRODUCTION DATA AND PROCESS VALIDATION RECORDS CONFIRMED THAT THE CASSETTE WELDING PROCESS REMAINS STABLE AND CAPABLE. BASED ON THE EVALUATION, THE REPORTED LEAK CONDITION AND ALARM IS CONFIRMED. THE INVESTIGATION IDENTIFIED EVIDENCE SUGGESTING A POTENTIAL LOCALIZED INNER CASSETTE LEAK ASSOCIATED WITH OVERHEATED PLASTIC DURING THE ULTRASONIC WELDING PROCESS, THEREFORE TRIGGERING THE TUBING SET PROBLEM ALARM. HOWEVER, REVIEW OF VALIDATED WELDING PARAMETERS, PRODUCTION RECORDS, AND ADDITIONAL PRODUCTION RUNS DEMONSTRATED THAT THE WELDING PROCESS WAS OPERATING WITHIN ESTABLISHED CONTROLS AND THAT NO SYSTEMIC MANUFACTURING ISSUE WAS PRESENT. THE REPORTED CONDITION IS CONSIDERED AN ISOLATED EVENT. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS, 3) 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS. REPORTING AS A CONSERVATIVE MEASURE DUE TO THE LEAK DURING EVALUATION. NO ADVERSE EFFECTS WERE REPORTED.