ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS SHOWED FLUID LEAKAGE ON THE FLOOR BELOW THE HEMODIALYSIS MACHINE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A U9000 ULTRAFILTER PRIOR TO USE FOR HEMODIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT.NO ADDITIONAL INFORMATION IS AVAILABLE.