ULTRAFILTER HECHINGEN

Description of Event or Problem

IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A U9000 ULTRAFILTER DURING HEMODIALYSIS. THE FILTER WAS USED FOR OVER 100 DAYS AND WAS NOT REPLACED AS REQUIRED. THE TREATMENT WAS DISCONTINUED HOWEVER THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

H11: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE DEVICE WAS EVALUATED ON SITE BY A QUALIFIED TECHNICIAN. A VISUAL AND TECHNICAL INSPECTION WERE PERFORMED, AND THE REPORTED MACHINE LEAK WAS CONFIRMED. THE FILTER WAS REPLACED, AND THE SIMULATION TREATMENT WAS NORMAL. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE RELATED TO USER ERROR AS THE FILTER HAD BEEN IN USE FOR 108 DAYS AND WAS NOT REPLACED WITHIN THE REQUIRED TIMEFRAME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.