ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 AND 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.

Description of Event or Problem

IT WAS REPORTED THAT AFTER TWO HOURS OF HEMODIALYSIS TREATMENT WITH A U9000, THE PATIENT EXPERIENCED GENERALIZED SWEATING AND DISCOMFORT. TREATMENT WAS STOPPED IMMEDIATELY. THE PATIENT WAS DISCONNECTED AND "BLOOD TRANSFUSION WAS INITIATED" (REPORTED AS "DISEMBARKED BLOOD TRANSFUSION" [SIC]). THE PATIENT WAS FOUND TO HAVE LOST 2KG IN WEIGHT AND ALSO EXPERIENCED LOW BLOOD PRESSURE. ADDITIONALLY, IT WAS REPORTED THAT ¿THE EVENT CAUSED PATIENT TOO MUCH ULTRAFILTRATION, TOO QUICKLY, CAUSING LOW BLOOD PRESSURE AND EVEN LIFE-THREATENING CONDITIONS¿. UPON INSPECTION OF THE MACHINE, AN EXTERNAL LEAK FROM THE ULTRAFILTER WAS IDENTIFIED. IT WAS REPORTED THAT THE MACHINE WAS REPLACED AND HEMODIALYSIS TREATMENT WAS CONTINUED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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