ORS-100 SOLUTION WARMER DRAPE

Additional Manufacturer Narrative

AFTER EXAMINING THE RETURNED DEVICE, THE "HOLE" IN QUESTION APPEARS TO BE A SMALL BURN HOLE. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING 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. BASED UPON THE EXAMINATION OF THE RETURNED PRODUCT, IT IS CONCLUDED THAT THIS EVENT WAS RELATED TO MISUSE BY THE CUSTOMER AND THEREFORE NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

THE SCRUB TECH NOTICED DURING SURGERY THAT THERE WAS SOME WATER UNDER THE FLUID WARMER DRAPE AND IN THE FLUID WARMER PAN. THE FLUID WARMER WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD. THE DRAPE WAS INSPECTED A COUPLE OF TIMES UNTIL A TINY HOLE WAS FOUND IN THE WARMER DRAPE. A NEW STERILE GRADUATE AND IRRIGATION BULB WAS GIVEN TO THE SCRUB TECH FILLED WITH A NEW WARM N.S. IT WAS DETERMINED THAT THERE WERE 8 LAPS MOISTENED WITH THE N.S. THAT WAS IN THE FLUID WARMER. THE SURGEONS WERE NOTIFIED AFTER THE HOLE WAS FOUND. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A STAPH INFECTION AT THE INCISION SITE, HOWEVER THE PATIENT DID HAVE MULTIPLE COMORBIDITIES AND IT WAS A LENGTHY PROCEDURE WHICH IS A HIGH RISK FOR INFECTION.