F6 DIALYZER FINISHED ASSY (CASE)

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

A REPORT HAS BEEN RECEIVED REGARDING AN EVENT WHICH OCCURRED FROM A HEMODIALYSIS USER FACILITY. REPORTEDLY, THE PT HAD BEEN RECEIVING DIALYSIS TREATMENT WHEN AN INTERNAL BLOOD LEAK WAS DETECTED. THE LEAK WAS REPORTED AS ¿GROSS¿ IN THAT VISIBLE BLOOD COULD BE SEEN ENTERING THE DIALYSATE. THERE WAS AN APPROXIMATE 157 ML OF BLOOD LOSS SINCE NO BLOOD WAS RETURNED TO THE PT. THE PT REQUIRED NO MEDICAL INTERVENTION; HOWEVER, A BLOOD TRANSFUSION WAS CONSIDERED. THE FACILITY WAS CONTACTED REGARDING THIS EVENT. IT WAS LEARNED THAT THE PT IS FINE WITH NO ILL EFFECT. ALSO, NO FURTHER INFO WILL BE RELEASED. A COMPANION SAMPLE IS AVAILABLE FOR EVALUATION.