ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6, H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE DID NOT IDENTIFY ANY PRODUCT ABNORMALITY THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAKAGE. A LEAK TEST WAS PERFORMED ON THE DIALYSATE SIDE OF THE FILTER, AND NO LEAK WAS DETECTED. 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 NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

B3: EVENT DATE: 12/2025. E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN ULTRAFILTER U9000 WAS OBSERVED TO BE CRACKED AND LEAKED DURING HEMODIALYSIS THERAPY. THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT MANUALLY AND DIALYSIS WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.