QINFLOW BLOOD & FLUID WARMER

Description of Event or Problem

AT 0846 A FIRE ALARM WAS ACTIVATED IN OUR PEDI OPERATING ROOM 19. IT WAS NOTED ANESTHESIA BLOOD WARMER ON IV POLE WAS SMOKING AND QUICKLY TURNED TO FLAMES. AT THIS POINT WATER WAS APPLIED AND FIRE EXTINGUISHER WAS ACTIVATED. FIRE WAS OUT AND PATIENT WAS UNAFFECTED. THE SYSTEM WAS SENT TO QUARANTINE

Additional Manufacturer Narrative

DESPITE MULTIPLE EFFORTS, WE WERE UNABLE TO REPLICATE A SIMILAR FAILURE SCENARIO IN OUR LAB. OUR INTERIM CONCLUSION IS THAT A FAILURE INITIATED IN ONE OF THE HARDWARE COMPONENTS, DUE TO AN ABNORMAL EXTREME EVENT AND THE COMPONENT'S PERFORMANCE DETERIORATED OVER PROLONGED OPERATION OF THE SYSTEM UNTIL FULL FAILURE. THIS ABNORMAL CONDITION IS COULD NOT BE ASSOCIATED WITH ANY DESIGN, WORKMANSHIP, OR END USERS' ACTIONS. FOLLOWING A COMPREHENSIVE INVESTIGATION, AND BASED ON THE AVAILABLE DATA, WE CLASSIFIED THIS EVENT AS A "SINGULAR EVENT". THE AFFECTED DEVICE WILL REMAIN IN THE POSSESSION OF THE MANUFACTURER FOR FUTURE INVESTIGATION, AS APPLICABLE.

Description of Event or Problem

AT 0846 A FIRE ALARM WAS ACTIVATED IN OUR PEDI OPERATING ROOM (B)(6). IT WAS NOTED ANESTHESIA BLOOD WARMER ON IV POLE WAS SMOKING AND QUICKLY TURNED TO FLAMES. AT THIS POINT WATER WAS APPLIED AND FIRE EXTINGUISHER WAS ACTIVATED. FIRE WAS OUT AND PATIENT WAS UNAFFECTED. THE SYSTEM WAS SENT TO QUARANTINE.