ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT APPROXIMATELY TWO HOURS AND 30 MINUTES AFTER STARTING HEMODIALYSIS TREATMENT WITH A U9000, THE FILTER WAS OBSERVED TO BE LEAKING. THE PATIENT REPORTED MUSCLE SPASMS AND THE BLOOD PRESSURE MEASURED AT 73/46 MMHG. TREATMENT WAS STOPPED WITH BLOOD RESTITUTION OF THE EXTRACORPOREAL CIRCUIT. TREATMENT WAS RESTARTED WITH A DIFFERENT FILTER AND TREATMENT WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6, H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.