ORS-320 SLUSH WARMER DISC DRAPE

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO INDICATE THE PATIENT DEVELOPED AN INFECTION. A SAMPLE WAS RECEIVED FOR EVALUATION. THE DRAPE WAS PLACED OVER A WARMER WITH WATER ADDED. DRAPE WAS LEFT ON THE WARMER FOR OVER 1 HOUR. NO LEAKS, TEARS, HOLES OR BURN MARKS WERE FOUND. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) PIECES THAT WERE MANUFACTURED FROM 09/17/17 TO 09/19/17. NO DEFECTS RELATED TO THE NONCONFORMANCE WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE AS NO LEAKS, TEARS, HOLES OR BURN MARKS WERE FOUND. SINCE THE REPORTED ISSUE WAS NO FOUND IN REVIEW OF THE SAMPLE AND NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION, NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

COMPANY REP REPORTED "I HAD THE DRAPE FROM THE CASE BUT THEY WANT TO KEEP IT IN CASE THEY NEED TO DO AN INVESTIGATION ON THEIR END. I AM SENDING ANOTHER DRAPE IN THE LOT. I WANT TO SEND IN A DRAPE FROM THE LOT TO BE CHECKED. I MET WITH THE CLINICAL MANAGER, SCRUB TECH, AND INFECTION PREVENTION. THERE IS A SMALL, BUT FAST LEAKING HOLE IN THE WARMER END. THIS OCCURRED LAST MONDAY. TESTING THE WARMER, HAD MINIMUM FLUID, DIDN'T USE SUCTION ON THE DRAPE, ETC. PATIENT WAS UNDER OBSERVATION AND NO SIGNS OF RELATED INFECTION. IN-SERVICE SCHEDULED FOR (B)(6) AND RECOMMENDED INTRATEMP AS AN ALTERNATIVE PRODUCT."