ORS-300N SOLUTION WARMER DRAPE

Additional Manufacturer Narrative

THIS EVENT WAS ASSOCIATED WITH ITEM NUMBER OM-ORS-300, LOT NUMBER 1036670 AND IS ASSOCIATED WITH THE POTENTIAL FOLLOWING ORS-300N NON STERILE MICROTEK LOT NUMBERS, D152231, D152171A, AND D152211. D152231 WAS MANUFACTURED ON 8/12/2015, D152171A ON 08/10/2015 AND D152211 WAS A LOT NUMBER THAT WAS NOT ASSIGNED. NO DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. SINCE A SAMPLE WAS NOT PROVIDED, THE NON-CONFORMITY COULD NOT BE CONFIRMED.

Description of Event or Problem

CUSTOMER HAD AN INSTANCE OF A FLUID WARMER DRAPE MELTING AND CREATING A SMALL HOLE DURING USE IN THE O.R. THE TEAM PULLED THE WARMER FROM SERVICE AND BIOMED HAS EVALUATED TO FIND NO PROBLEM IN THE EQUIPMENT ITSELF. THE STAFF REPORTS THE DRAPES ARE MUCH THINNER NOW AND THEY ARE CONCERNED THE QUALITY CONTRIBUTED TO THIS BREAK IN STERILITY/INTEGRITY. THE TEMP WAS SET AT 120 DEGREES FAHRENHEIT AS PER PROPER USE AND HAS NO SETTINGS ABOVE THAT. MEDICAL ACTION IS A CONTRACTOR FOR THESE DRAPES AND A COMPLAINT WAS SUBMITTED TO MEDICAL ACTION AS WELL TO OBTAIN THE NONSTERILE PRODUCT AND LOT NUMBER USED TO PACKAGE THE STERILE DRAPE FROM MEDICAL ACTION.