MEDEX IV FILTER EXTENSION SET

Additional Manufacturer Narrative

NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION FOUND A CRACK ON THE FEMALE PORT OF THE BLUE FILTER. FUNCTIONAL TESTING FOUND THE SAMPLE EXHIBIT LEAKAGE AT FEMALE PORT OF THE BLUE FILTER. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. AS THE CONDITION OBSERVED COULD BE PRODUCED DUE TO A MISHANDLING OF THE PRODUCT. AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD. THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS LEAKING FLUID. LIPID FILTER TO HAVE A SMALL DROP OF LIPIDS LEAKING FROM CONNECTION SITE. NO PATIENT INJURY WAS REPORTED.