CO-SET KIT

Description of Event or Problem

PT WAS TRANSFERRED TO ICU POST AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFT X3 WITH PLACEMENT OF SWAN GANZ CATHETER. WHEN RN ATTEMPTED TO CONNECT THE CO-SET AT THE PROXIMAL END (THE LUER LOCK CONNECTION), THERE WAS LEAKING NOTED AT THE SITE OF THE LUER LOCK. THIS REQUIRED REPLACEMENT OF THE ENTIRE CO-SET SYSTEM. AFTER CO-SET WAS CHANGED THERE WAS NO ADD'L LEAKAGE NOTED FROM THE LUER LOCK SITE. PT TOLERATED THE PRODUCT EXCHANGE. FDA PRODUCT SAFETY REPORT ID# (B)(4).