REVEACLEAR DIALYIZER

Description of Event or Problem

VISIBLE BLOOD LEAK NOTED IN THE DIALYZER AT 7:55 AM WHILE PT WAS UNDERGOING HD TREATMENT. HD MACHINE ALARMED (BLOOD LEAK DETECTED). PLACED MACHINE IN BYPASS MODE AND BLOOD PUMP STOPPED. THE ENTIRE SYSTEM WAS DISCARDED WITHOUT RETURNING THE BLOOD. APPROXIMATE BLOOD LOSS WAS 200 ML PER EXTRA CORPOREAL CIRCUIT VOLUME. NEW SYSTEM WAS SET UP AND RESUMED TREATMENT WITHOUT ANY PROBLEM. VITAL SIGNS STABLE AND MONITORED. ALARM: BLOOD IN DIALYSATE DURING HD TREATMENT AT 0755, (B)(6) 2014. DIALYZER: REVACLEAR DIALYZER BY GAMBRO DIALYSIS TREATMENT WAS STOPPED IMMEDIATELY AND BLOOD WAS NOT RETURNED (200 ML BLOOD LOSS). GAMBRO QUALITY MANAGEMENT WAS NOTIFIED (B)(4). GAMBRO WILL SEND A PACKAGING KIT SO THAT (B)(6) CAN SEND DIALYZER TO GAMBRO TOMORROW, (B)(6) 2014 FOR ANALYSIS AND QUALITY CHECK. PT WAS HOOKED UP TO X36 PHOENIX GAMBRO MACHINE PH 25643 -MACHINE WAS PULLED OUT OFF THE DIALYSIS FLOOR IMMEDIATELY AFTER ALARM WENT OFF. NEW DIALYZER AND NEW MACHINE WERE USED. GAMBRO REP WILL CHECK DIALYSIS MACHINE TOMORROW, (B)(4) 2014.