ULTRAFILTER HECHINGEN

Description of Event or Problem

IT WAS REPORTED THAT DURING THE HEMODIALYSIS TREATMENT WITH U9000, THE PATIENT COMPLAINED OF CRAMPS AND DECREASED BLOOD PRESSURE. AFTER THE TREATMENT, THE PATIENT EXPERIENCED 0.7 KG MORE DEHYDRATION THAN THE ACTUAL DEHYDRATION SET AMOUNT OF 1.2 KG. IT WAS ALSO REPORTED THAT DUE TO WATER LEAKAGE FROM THE BACTERIAL FILTER U9000, THE "SYSTEM BALANCE" OF THE EQUIPMENT WAS "DESTROYED" WHICH RESULTED IN EXCESSIVE DEHYDRATION. SUBSEQUENTLY, THE PATIENT WAS GIVEN FLUID REHYDRATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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.