ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS- (B)(6). THE DEVICE WAS RECEIVED, AND PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS AND ACTUAL SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING WAS PERFORMED ON THE DEVICE DIALYSATE SIDE, AND NO LEAKAGE WAS OBSERVED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS NOT VERIFIED. 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 PLUS ULTRAFILTER DURING PREPARATION TESTING FOR HEMODIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION: F11, F12. THE INITIAL REPORT INADVERTENTLY INCLUDED INFORMATION IN F11: REPORT SENT TO FDA AND F12: LOCATION WHERE EVENT OCCURRED. THIS INFORMATION IS BEING REMOVED AS THIS MDR IS A MANUFACTURER MDR (AND NOT AN IMPORTER MDR). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.