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 DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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 REPORTED LEAKAGE WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE CONDUCTED. 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 TWO (2) U9000 ULTRAFILTERS AFTER A "FEW DAYS OF USE" FOR HEMODIALYSIS THERAPY WITH AN AK96 MACHINE. THE MACHINE ALARMED WHEN THE LEAKS WERE DETECTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.