OPTIFLUX F200NRe HF 12/CS 1.9SA EBEAM

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A NURSE REPORTED THAT DURING A HEMODIALYSIS (HD) TREATMENT THERE WAS A DIALYZER BLOOD LEAK. IN A FOLLOW UP, THE NURSE SAID THE LEAK OCCURRED LESS THAN 15 MINUTES INTO THE HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DESCRIBED AS BEING AN INTERNAL LEAK AND WAS SEEN IN THE ARTERIAL HANSEN LINE. BLOOD TESTS STRIPS WERE NOT USED. THE FRESENIUS 2008T DIALYSIS MACHINE DID ALARM WITH A BLOOD LEAK ALARM. FRESENIUS BLOODLINES WERE BEING USED.THERE WAS NO DAMAGE NOTED ON THE DIALYZER. THERE WAS PATIENT BLOOD LOSS OF 200-300 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REPORTED. THE PATIENT FINISHED TREATMENT ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT¿S INITIALS ARE (B)(6), DOB (B)(6) 1982. THE PATIENT GENDER IS MALE. THE WEIGHT IS 127KG. THE PATIENT¿S DIALYSATE FLOW RATE (DFR) WAS 800 ML/MIN AND BLOOD FLOW RATE (BFR) WAS 450 ML/MIN. THE PATIENT DIALYZES 3 TIMES PER WEEK. THE PATIENT HAS BEEN DOING HD TREATMENT FOR 2.5 YEARS.