PROBES, DISPOSABLE SKIN TEMP, STERILE

Additional Manufacturer Narrative

(B)(4)- PER INITIAL COMPLAINT DETAILS, THE COMPLAINT SAMPLE HAS BEEN DESTROYED AND THE LOT NUMBER IS UNKNOWN. NO FURTHER EVALUATION WILL BE COMPLETED. THE REPORTED PRODUCT CODE (M1024222) HAS BEEN SET TO END OF LIFE AND IS NO LONGER MARKETED BY CAREFUSION. (B)(4).

Description of Event or Problem

DIFFERENT VALUES WHEN MEASURING WITH SKIN TEMPERATURE PROBE AND FOLEY CATHETER PROBE. THE PATIENT WAS IN ICU AND CAREFUSION SKIN PROBE WAS USED FOR TEMPERATURE MEASURING. THE PATIENTS TEMPERATURE VALUES (MEASURED FROM ARMPIT) WERE 37,1- 36,6 -35,3 BY AN HOUR. THE NURSE HAD A FEELING (WHEN TRIED PATIENT SKIN WITH THE HAND) THE PATIENT´S SKIN WAS HOT AND THEN HE/SHE MEASURED TEMPERATURE FROM THE EAR AND THE VALUE WAS 39,9. THEN PATIENT FOLEY CATHETER WAS CHANGED TO THE ONE WHICH MEASURES TEMPERATURE (COVIDIEN). THEN THE VALUE WAS 40,1°C. THE CONCLUSION WAS THAT OUR SKIN TEMPERATURE PROBE DIDN´T GIVE RIGHT RELIABLE VALUES. CUSTOMER REPORTED: ¿TEMPERATURE HAD BEEN PROBABLY DANGEROUSLY HIGH ALREADY A LONG TIME BEFORE NOTICED. THEN THEY HAD TAKEN A BLOOD CULTURES AND CONTACTED NEUROLOGIST AND INFECTION DOCTOR AND ADDED ANTIBIOTICS FOR THE PATIENT.¿