ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6, H11 H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS SHOWED TWO (2) FILTERS ATTACHED TO THE DIALYSIS MACHINE HOLDER IN THE BACK OF THE DEVICE. FLUID DROPLETS WERE VISIBLE OUTSIDE OF THE FILTERS IN THE HOLDER AREA. ANY SPECIFIC DEFECT THAT ALLOWED THE LEAKAGE WAS NOT VISIBLE. 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 LEAK 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.

Additional Manufacturer Narrative

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 UNSPECIFIED LOCATIONS OF TWO (2) U9000 PLUS CN ULTRAFILTERS DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.