ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

THE DEVICE WAS EVALUATED ON SITE BY A QUALIFIED TECHNICIAN. VISUAL INSPECTION WAS PERFORMED AND THE TECHNICIAN CONFIRMED A LEAK. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE LEAKAGE EVENT WAS DETERMINED TO BE RELATED TO A CRACK IN THE HOUSING NEAR THE WELDING ZONE. THE FILTER WAS REPLACED. A PREVIOUS NONCONFORMANCE WAS OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER ADDRESS: (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 ORIGINATING FROM AN UNSPECIFIED LOCATION OF A U9000 ULTRAFILTER DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.