MST-H-9-6-18 HS2

Additional Manufacturer Narrative

TESTING PERFORMED ON SITE AT THE HEALTHCARE FACILITY FOUND THAT THE STERILIZER'S UNLOADING AUTOMATION WAS FULLY FUNCTIONAL, OPERATING AS DESIGNED. HOWEVER, IT WAS OBSERVED THAT THE CSPD STAFF WAS LOADING THE BATCH CARTS MANUALLY, POTENTIALLY AFFECTING THE RACKS' POSITION INSIDE THE CHAMBER AND THUS PREVENTING SUCCESSFUL UNLOADING. THE CSPD MANAGER WAS INFORMED OF THE SITUATION, STRESSING THE IMPORTANCE OF USING THE LOADING AUTOMATION FOR PROPER RACK POSITIONING INSIDE THE CHAMBER. THE FOLLOWING FIELDS WERE MODIFIED IN THIS SUPPLEMENT REPORT> B1, B4, G3, G6, H2, H6, H11.

Additional Manufacturer Narrative

INVESTIGATION OF THE INCIDENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE STERILIZER, EQUIPPED WITH A GROUND-LOADING SYSTEM AND DESIGNED FOR AUTOMATIC LOADING AND UNLOADING, EXPERIENCED A MALFUNCTION DURING THE UNLOADING PROCESS. DURING THE INCIDENT, THE UNLOADING FUNCTION EXECUTED ONLY PARTIALLY, LEAVING THE SECOND CART INSIDE THE UNIT. THE SPD TECHNICIAN ATTEMPTED TO MANUALLY REMOVE THE SECOND CART USING A METAL ROD. IN THE PROCESS SHE BACKED UP INTO A HOT RACK THAT HAD BEEN LEFT THERE TO COOL DOWN, RESULTING IN BURNS WITH BLISTERING AND PEELING ON HER ARM. MEDICAL CARE WAS PROVIDED BY EMPLOYEE HEALTH SERVICES AND THE TECHNICIAN WAS ABLE TO RETURN TO WORK.