PHOENIX

Description of Event or Problem

GAMBRO RECEIVED A REPORT FROM A CUSTOMER WHO COMPLAINED THAT THREE NURSES SUSTAINED BURNS WHEN CONCENTRATE TUBING CAME OFF OF THE BLUE MALE CONCENTRATE CONNECTOR ASSEMBLY INSERTED INTO THE LOWER FRONT PANEL ON A PHOENIX MACHINE. THE EVENTS OCCURRED ON THREE DIFFERENT MACHINES WHICH WERE ALL EQUIPPED WITH THE SOFTWARE VERSION 3.34. (FOR THE OTHER EVENTS REFER TO MDR 9616240-2008-00036 AND MDR 9616240-2008-00038). HOT WATER WAS SPRAYED ONTO THE RIGHT ANKLE OF THE FACILITY'S NURSE WHILE THE DEVICE WAS UNDERGOING HEAT DISINFECTION. THE NURSE WAS DIAGNOSED WITH SECOND-DEGREE BURNS AND WAS TREATED AT THE EMERGENCY DEPT AT THE HOSPITAL. THE MACHINE WAS INSPECTED BY THE CLINIC'S BIOMEDICAL TECHNICIAN WHO FOUND THAT THE CONCENTRATE TUBING AND THE TUBING CLIP HAD COME LOOSE FROM THE MALE CONNECTOR ASSEMBLY. HE REPLACED THE TUBING AND THE CLIP BACK ONTO THE MALE CONNECTOR ASSEMBLY. THE MACHINE WAS RETURNED TO SERVICE WITHOUT ANY FURTHER TUBE DISCONNECTION EVENT.