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 AFTER TWO HOURS OF STARTING THE DIALYSIS TREATMENT WITH ULTRAFILTER U9000, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. THE PATIENT WAS GIVEN LOW-TEMPERATURE HIGH-SODIUM DIALYSIS. AFTER 3 HOURS AND 30 MINUTES OF DIALYSIS, IT WAS FOUND THAT THE PATIENT WAS SWEATING SIGNIFICANTLY. DIALYSIS WAS STOPPED. THE BLOOD WAS RETURNED AND THE BLOOD PRESSURE READING WAS 95/62 MMHG. THE SWEATING WAS STOPPED. HOWEVER, AFTER DIALYSIS THE PATIENT LOST 3.8 KG AND REFUSED SALINE INFUSION. THE PATIENT WAS LAID FLAT AND RESTED BEFORE LEAVING. LATER IT WAS FOUND THAT AN EXTERNAL FLUID LEAK CAUSED EXCESSIVE ULTRAFILTRATION. U9000 WAS REPLACED AND THE MACHINE FUNCTIONED NORMALLY AFTERWARDS. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED 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.