OPTIFLUX F160NRE HF 12/CS 1.5SA EBEAM

Description of Event or Problem

A USER FACILITY PATIENT CARE TECHNICIAN (PCT) NOTED APPROXIMATELY 5-10 MINUTES INTO TREATMENT A WEIRD PATTERN ON DIALYZER FIBERS. UPON FOLLOW UP, THE CLINIC MANAGER REPORTED THAT THE WEIRD PATTERN APPEARED TO BE A BLOOD CLOT TRAVELING OUTSIDE OF THE FIBERS. THE CLINIC MANAGER STATED THAT THE MACHINE, A FRESENIUS 2008T MACHINE WITH SERIAL NUMBER (B)(6), DID NOT ALARM WITH A BLOOD LEAK ALARM AND WAS PULLED FROM SERVICE. THE MACHINE WAS FIXED AND RETURNED TO SERVICE BUT IT IS UNKNOWN IF THE BLOOD LEAK DETECTOR NEEDED TO BE CALIBRATED, CLEANED, OR REPLACED. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE. THE LEAK WAS NOT VISUALLY OBSERVED JUST THE WEIRD PATTERN ON THE DIALYZER FIBERS. FRESENIUS BLOODLINES WERE USED FOR TREATMENT. THE CLINIC MANAGER REPORTED THAT THE LEAK WAS INTERNAL. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON A DIFFERENT MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE CLINIC MANAGER STATED THAT THE DIALYZER IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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