SLUSH/WARMER

Additional Manufacturer Narrative

AN AREA OF THE SLUSH/WARMER DISC- DRAPE OVERHEATED, BURNING A SMALL HOLE THAT ALLOWED THE SALINE SOLUTION IN THE WARMING DEVICE TO BECOME OVERHEATED. CONTAMINATION OF THE SALINE SOLUTION IN THE WARMING DEVICE IS CLEARLY UNACCEPTABLE BUT THIS CANNOT HAPPEN WHEN THE DEVICE IS PROPERLY OPERATED. AN INVESTIGATION BY (B)(4) ASSIGNED TO (B)(6), DETERMINED THAT A HOSPITAL EMPLOYEE TURNED ON THE DEVICE WITHOUT FIRST CHECKING TO MAKE SURE THAT THE DEVICE WAS READY TO OPERATE. USER INSTRUCTIONS EMPHASIZE THAT THERE MUST BE FLUID IN THE BASIN TO PREVENT SUCH AN OCCURRENCE. BIOMED GROUP AND ACCOUNT EXECUTIVE HAVE BEEN WORKING WITH THE HOSPITAL STAFF. THIS ISSUE WAS EXPLAINED TO THEM, THE EQUIPMENT WAS REPAIRED AND RUSH UNIVERSITY MEDICAL CENTER HAS ELECTED TO KEEP THIS DEVICE AS IT WORKS SATISFACTORILY WHEN PROPERLY OPERATED. WE BELIEVE NO FURTHER INVESTIGATION IS REQUIRED AS THE DEVICE WORKS AS INTENDED WHEN PROPERLY MAINTAINED AND OPERATED.

Description of Event or Problem

ON (B)(6) 2014 REC'D MEDWATCH REPORTED THROUGH EMAIL FROM (B)(6) LOCATION. THE COMPLAINT REPORTED WAS ABOUT THE HOLE ON THE ORS-320 SLUSH DRAPE. THE WARMER/SLUSH WAS OVERHEATED CAUSING A BURN AREA WITH A SMALL HOLE. THIS THEN CAUSED CONTAMINATION OF THE SALINE SOLUTION IN THE BASIN.