F3 DIALYZER FINISHED ASSY

Description of Event or Problem

A HEMODIALYSIS USER FACILITY HAS REPORTED THE FOLLOWING INCIDENT: WITHIN 4 MINUTES OF STARTING HEMODIALYSIS, THE ALARM INDICATED A MINOR BLOOD LEAK WHICH WAS CONFIRMED BOTH VISUALLY AND WITH THE USE OF A REAGENT TEST STRIP. THE FACILITY WAS CONTACTED REGARDING THIS EVENT AND THE FOLLOWING NEW INFO WAS LEARNED. THE AMOUNT OF BLOOD LOSS WAS ESTIMATED TO BE 48 ML'S. THE TREATMENT WAS STOPPED AND THE PT WAS TRANSFUSED WITH 250 ML'S OF BLOOD. THE REPORTER OF THE EVENT STATED THAT THE PT WAS CRITICALLY ILL BOTH PRIOR TO THIS EVENT AND AFTER THE TRANSFUSION AND THAT THE TRANSFUSION GIVEN, WAS FOR OTHER THAN JUST THE DIALYZER LEAK. THIS PT WAS RE-STARTED ON DIALYSIS WITH USE OF A NEW TREATMENT SET, AND REMAINS IN THE SAME CRITICAL STATUS IN THE PEDIATRIC ICU UNCHANGED SINCE THIS EVENT. THIS PT CONTINUES HEMODIALYSIS AS ORDERED. THERE IS NO SAMPLE.

Additional Manufacturer Narrative

(B)(6).