Description of Event or Problem · 1
SMALL BLISTERS WERE NOTED ON PATIENT'S SKIN AT THE TCM (TEMPERATURE CONTROL MODULE) SITE. THE TCM WAS ON THE PATIENT FOR FOUR HOURS AT 40 DEGREES CENTIGRADE. THE PATIENT EXPIRED UNRELATED TO THIS EVENT. THE BLISTER/BURN IS THOUGHT TO BE DUE TO THE NEW PHILIPS TCG10 MONITOR THAT WAS SET AT 40 DEGREES. THE NEW TCG10 MONITORS WERE INSTALLED IN THE NICU (NURSERY INTENSIVE CARE UNIT) ONLY 5 DAYS BEFORE THIS EVENT. PHILIPS RECOMMENDS SETTING THE TEMPERATURE OF 43 DEGREES, BUT RESPIRATORY THERAPY (RT) AND THE PHYSICIANS AGREED THAT THIS SEEMED TOO HIGH, SO THEY SET THE TEMPERATURE AT 40 DEGREES. THE BABY ONLY WEIGHED 1.243 KG, SO THE HEAT COMING FROM THE TCG10 AND RADIOMETER "TC SENSOR 84" MAY HAVE BEEN THE CAUSE OF THE BURN. THE PHYSICIANS AND RT STAFF COLLABORATED AFTER THE INCIDENT AND DECIDED TO LOWER THE TEMPERATURE EVEN FURTHER (TO 37 DEGREES). THE MONITOR PCO2 WAS STILL ACCURATE AT THIS TEMPERATURE. A WORK ORDER (WO) TO BIOMED WAS PLACED TO ENSURE THAT THE NEW TCG10 AND THE RADIOMETER "TC SENSOR 84" THAT ATTACHES TO IT ARE OPERATING WITHIN THE SPECIFICATIONS AND RUNNING TRUE TO TEMPERATURE.THE PATIENT SUSTAINED A 1ST DEGREE BURN (SMALL BLISTER). THE EXACT SIZE IS UNKNOWN, IT WAS NOT MEASURED. BUT THE BLISTER WAS "SMALL" AND DIRECTLY UNDER THE PROBE SITE. THE PROBE IS ABOUT 0.5 INCHES IN DIAMETER, SO THE SITE WAS SMALL. THE TREATMENT WAS NOT LISTED, BUT THEY DID MOVE THE PROBE TO A NEW SITE. THEY MOVE IT EVERY 3-4 HOURS PER PROTOCOL ANYWAY, WHICH IS WHY THEY NOTICED THE BURN AT 4 HOURS. THERE WAS NO CHEMICAL ON SKIN, BUT THERE IS A GEL USED UNDER THE PROBE THAT IS REQUIRED FOR THIS SPECIFIC APPLICATION.======================MANUFACTURER RESPONSE FOR TCGAS MODULE, TCG10 (PER SITE REPORTER)======================PHILIPS REPRESENTATIVE WAS NOTIFIED AND SHE IS LOOKING INTO THE SITUATION. SHE REPORTED TO PHILIPS CORPORATE AND IS TAKING THIS VERY SERIOUSLY.