ECOLAB

Description of Event or Problem

AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # OEM-ORS-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(4) 2015 ORIGINATED BY (B)(6) OF (B)(6) MEDICAL CENTER STATING "ACCORDING TO STAFF, AFTER COMPLETION OF A SURGICAL PROCEDURE, WHEN THE DRAPES WERE REMOVED AND PATIENT WAS READY TO BE TRANSFERRED TO PACU, IT WAS NOTED THAT A STERILE DRAPE BEING REMOVED FROM SOLUTION WARMER HAD LIQUID ON THE OUTSIDE OF THE DRAPE INDICATING THERE WAS A HOLE IN THE DRAPE. PHYSICIAN WAS NOTIFIED. TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY WAS THE PROCEDURE THAT WAS PERFORMED WHEN LEAK IN DRAPE NOTED." AVID MEDICAL AND ECOLAB WERE BOTH NOTIFIED OF THIS COMPLAINT ON (B)(6) 2015 BY THE ORIGINATOR (B)(6) OF (B)(6) MEDICAL CENTER. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4)TO ECOLAB FOR LEAK IN THE WARMING DRAPE PART # OEM-ORS-300N. THE FOLLOWING WARMER DRAPE LOTS WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY D151591RC, D15161RC, D151611RC, D151601RC, D152161RC, D143371RC, D142401RC. NO FURTHER INFORMATION ON THE PATIENT IS AVAILABLE.