AQUADEX SYSTEM

Description of Event or Problem

GAMBRO RECEIVED A VOLUNTARY MEDWATCH REPORT THAT STATED A PATIENT WITH A COMPLEX MEDICAL HISTORY WAS ADMITTED TO THE HOSPITAL SECONDARY TO UNEXPECTED WEIGHT GAIN AND SHORTNESS OF BREATH. FOUR DAYS AFTER AQUAPHERISIS WAS INITIATED, THE PATIENT¿S URINE TURNED A DARK MAROON COLOR AND THE ULTRAFILTRATE WAS PINK TINGED. THE PATIENT MAY HAVE DEVELOPED ACUTE KIDNEY INJURY. THE CLINICAL INVESTIGATION IS ONGOING. LIMITED INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

Additional Manufacturer Narrative

LIMITED INFORMATION HAS BEEN PROVIDED WITH REGARD TO THIS EVENT. IT WAS NOTED THAT THE ULTRAFILTRATE HAD A ¿PINK TINT¿ TO IT. ULTRAFILTRATE IS NORMALLY COLORLESS OR A LIGHT STRAW COLOR. PRESENCE OF EVEN A SMALL AMOUNT OF BLOOD GIVES THE ULTRAFILTRATE A BRIGHT RED COLOR. PINK TINT TO THE ULTRAFILTRATE COULD INDICATE THAT THERE IS SOME BLOOD LEAKAGE INTO THE ULTRAFILTRATE DUE TO A BROKEN FIBER IN THE FILTER. HOWEVER, IN TESTS PERFORMED TO DETERMINE THE DISCOLORATION DUE TO BLOOD LEAKAGE, THE RESULTS DEMONSTRATED THAT A SMALL AMOUNT OF BLOOD (1-2 ML) IN A LITER BAG OF FLUID WOULD RESULT IN A COLORMETRIC CHANGE OF MORE THAN JUST A TINT. THE CUSTOMER HAS NOT MADE THE SERIAL NUMBER OF THE CONSOLE KNOWN; THEREFORE, GAMBRO COULD NEITHER PERFORM A DEVICE HISTORY RECORD CHECK NOR A COMPLAINT FILE CHECK FOR THE CONSOLE. THE CUSTOMER HAS NOT MADE THE LOT NUMBER OF THE CIRCUIT KNOWN; THEREFORE, GAMBRO COULD NEITHER PERFORM A DEVICE HISTORY RECORD CHECK NOR A COMPLAINT HISTORY FILE CHECK FOR THE CIRCUIT. THIS EVENT WAS ORIGINALLY SUBMITTED TO FDA ON (B)(4) 2014 WITH MFR RPT # 3003504604-2013-00003 WHICH WAS INCORRECT. THE CORRECT MFR RPT # IS 3003504604-2014-00001. DEVICE NOT RETURNED TO MFG; DEVICE SN AND LOT NUMBER HAVE NOT BEEN PROVIDED.