ULTRAFILTER HECHINGEN

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED, 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 EXCESSIVE FLUID REMOVAL WAS OBSERVED DURING THERAPY. IT WAS FURTHER REPORTED THAT A LEAK FROM AN UNSPECIFIED ULTRAFILTER WAS OBSERVED. THE ULTRAFILTER WAS REPLACED WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.