ASAHI REXEED SERIES DIALYZERS

Description of Event or Problem

THE PT WAS TREATED ON HEMODIALYSIS USING THE REXEED-21R DIALYZER ON (B)(6) 2010. THE DIALYSIS EQUIPMENT ALARMED THE BLOOD LEAKAGE TWO OR THREE MINUTES AFTER STARTING THE EXTRACORPOREAL CIRCULATION. THE BLOOD CIRCULATION WAS STOPPED IMMEDIATELY. THE DIALYZER (THE PRODUCT FROM THE SAME BOX) AND THE BLOOD TUBE SET WERE REPLACED AND THE DIALYSIS TREATMENT WAS STARTED AGAIN. BUT THE EQUIPMENT WARNED THE BLOOD LEAKAGE AGAIN IN THE SAME TIMING AS THE FIRST TIME. THE DIALYZER (THE PRODUCT FROM THE SAME BOX) AND THE TUBE SET WERE CHANGED TO NEW ONES, AND THE TREATMENT WAS TRIED AGAIN. BUT THE EQUIPMENT DETECTED THE BLOOD LEAKAGE AGAIN. IN THE FOURTH TIME, THE NEW DIALYZER PICKED UP FROM THE DIFFERENT BOX. BUT THE BLOOD LEAK WAS DETECTED JUST AFTER RESTARTING THE BLOOD CIRCULATION. THE PT LOST ABOUT THE 1000ML OF BLOOD BECAUSE THE 250ML OF BLOOD REMAINED IN THE DIALYZER AND BLOOD TUBING SET WAS DISCARDED EACH TIME. THE BLOOD TRANSFUSION WAS NEEDED FOR THE PT IN THE ADDITIONAL HOSPITAL DAY.

Additional Manufacturer Narrative

WE CHECKED THE QUALITY RECORDS INCLUDING THE MATERIAL INCOMING INSPECTIONS, IN-PROCESS TESTS AND THE PRODUCT RELEASE INSPECTION. HOWEVER, NO ABNORMALITY WAS FOUND. THE LEAKAGE TEST WAS PERFORMED ON EACH PRODUCT DURING THE MANUFACTURING PROCESS. AND NON-CONFORMING PRODUCTS ARE NOT RELEASED FROM THE PLANT. SO THE BROKEN HOLLOW FIBER THAT MAY CAUSE THE BLOOD LEAKAGE COULD BE CAUSE BY INADEQUATE CONDITION OF TRANSPORTATION, STORAGE, AND/OR HANDLING OF PRODUCTS.