ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

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 FROM A U9000 ULTRAFILTER DURING HEMODIALYSIS THERAPY WITH AN AK96 MACHINE. THE MACHINE DID NOT ALARM. THE PATIENT WEIGHED 0.5KG MORE THAT THEIR ACTUAL WEIGHT AT THE END OF TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.