Description of Event or Problem · 1
NEUROSURGERY ICU PATIENT WAS FOUND TO HAVE FROSTBITE ON BOTH THIGHS OVER 2% OF BODY SURFACE AREA. A PUNCH BIOPSY REVEALED FULL THICKNESS SKIN DAMAGE IN SOME PLACES. WOUND WAS DEBRIDED. THIS PATIENT HAD BEEN EXPERIENCING SHIVERING. SHIVERING CAN NATURALLY INCREASE THE TEMPERATURE OF THE BODY. THE DEVICE WILL RESPOND TO AN INCREASE IN BODY TEMPERATURE BY FURTHER COOLING THE BODY UNTIL IT REACHES A PRESET TEMPERATURE. THE STAFF WAS NOT INSTRUCTED TO TREAT THE SHIVERING. THE CORRELATION BETWEEN SHIVERING AND WATER TEMPERATURE WAS NOT MADE DURING THE ORIGINAL IN-SERVICES. THE INITIAL IN-SERVICE ON THIS PRODUCT BY THE MANUFACTURER WAS CONDUCTED 9 MONTHS AGO. THE CONNECTION IN TIME BETWEEN THE "INCIDENT" AND THE MANUFACTURER PRESENCE FOR IN-SERVICES (IN FEBRUARY) WAS PURELY COINCIDENTAL. THE IN-SERVICES WERE PLANNED PRIOR TO THE "INCIDENT". WE INVITED THEM TO RE-IN-SERVICE THE STAFF BECAUSE OF THE LENGTH OF TIME SINCE THE ARTIC SUN HAD BEEN USED ON THE UNIT. WE FELT TOO MUCH TIME HAD PASSED AND THAT RE-IN-SERVICING WAS NECESSARY FOR THE SAFE USE OF THIS PRODUCT. DURING THE RE-IN-SERVICE, STAFF WAS TOLD THAT THE WATER TEMPERATURE OF THE DEVICE SHOULD BE MONITORED ON AN HOURLY BASIS AND THAT THE PATIENT SHOULD NOT BE EXPOSED TO TEMPERATURES LESS THAN 10 DEGREES CELSIUS FOR LONGER THAN FOUR HOURS. THIS INFORMATION HAD NOT BEEN SHARED BY THE MANUFACTURER AT THE ORIGINAL IN-SERVICE NINE MONTHS AGO. IT IS BELIEVED THAT THE COMBINATION OF SHIVERING AND THE RESPONSE OF THE DEVICE TO THE SHIVERING (CIRCULATION OF COLDER WATER TO REDUCE THE INCREASE IN BODY TEMPERATURE) MAY HAVE LEAD TO THE FROSTBITE. ADDITIONALLY, STAFF UNDERSTOOD THAT THE DEVICE PADS WERE TO BE CHANGED EVERY 72 HOURS BUT COULD REMAIN ON THE PATIENT FOR UP TO 5 DAYS IF THE ADHESIVE WAS INTACT. CLINICIANS WERE NEVER TOLD TO CHECK UNDER THE PADS AND THEY WERE NEVER TOLD TO ASSESS THE SKIN FOR DAMAGE. THE SIZE OF THE PATIENT MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE FROSTBITE. THE PADS ARE SUPPOSED TO COVER AT LEAST 40% OF THE BODY SURFACE AREA. IF THE PADS COVER LESS THEN 40% THEN THE COLD "THERAPY" IS CONCENTRATED IN A SMALLER AREA THUS EXPOSING THE SKIN UNDER THE PADS TO LOWER TEMPERATURES. THIS PATIENT WAS "LARGE" SO THE AMOUNT OF BODY SURFACE COVERAGE MAY NOT HAVE BEEN 40%. FINALLY, THE CORE BODY TEMPERATURE IS MEASURED BY A THERMISTOR ATTACHED TO A FOLEY CATHETER. THIS PART OF THE DEVICE HAD BEEN PROVIDED BY THE MANUFACTURER BUT WAS NOT SAVED AFTER THIS INCIDENT. IN A JANUARY 2005 RECALL, 67 ARTIC SUN TEMPERATURE MANAGEMENT SYSTEMS WERE RECALLED FOR "INACCURACY OF THE PRIMARY PATIENT TEMPERATURE READING THAT IS USED TO MONITOR AND CONTROL PATIENT TEMPERATURE." NO ACCURACY TESTING WAS PERFORMED ON THE THERMISTOR BEFORE DISPOSAL.