ULTRAFILTER U9000

Additional Manufacturer Narrative

CORRECTION: D4: LOT NUMBER 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 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 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6, H11. SIX (6) COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, NO CONSPICUOUS FEATURES RELATED TO THE REPORTED FAILURE WERE IDENTIFIED. THE PROCESS DATA WAS REVIEWED BASED ON THE COMPANION SAMPLE BARCODES, AND NO ISSUES WERE NOTED. 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 TWO (2) U9000 ULTRAFILTERS DURING HEMODIALYSIS THERAPY WITH AN AK95 MACHINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.