3M STERI-VAC STERILIZER/AERATOR 5XL

Additional Manufacturer Narrative

THERE WERE TWO UNITS THAT WERE PLACED ON EACH OTHER. ONE UPPER AND ONE LOWER. THE UPPER UNIT WAS REPORTED TO BE ON ACCELERATED MODE AND HAD A SERIAL NUMBER OF (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A MALE EMPLOYEE WITHIN THE HOSPITAL STERILIZATION FACILITY WAS EXPOSED TO EO WHEN A FEMALE OPERATOR OF THE 3M EO STERILIZER OPENED THE DOOR PRIOR TO FULL AERATION AFTER BEING INFORMED TO ABORT CYCLE. IT WAS REPORTED THE STERILIZER WAS ON ACCELERATED MODE WHEN THE EVENT OCCURRED. THE ACCELERATED MODE SHOULD NOT HAVE BEEN USED FOR A STANDARD STERILIZATION PROCESS FOR THIS MODE IS ONLY APPLICABLE WHEN UNIT IS BEING SERVICED. USER ERROR CONTRIBUTED TO THIS EVENT. THE MALE EMPLOYEE SOUGHT MEDICAL CONSULTATION AT THE OCCUPATIONAL HEALTH CLINIC WITHIN THE HOSPITAL. IT WAS REPORTED THAT THE EMPLOYEE EXPERIENCED A HEADACHE. AT THIS TIME, IT IS NOT KNOWN WHETHER ANY MEDICAL INTERVENTION WAS ADMINISTERED FOR THE HOSPITAL WOULD NOT RELEASE THIS INFO. THE ESTIMATED EXPOSURE TIME TO THE OPERATOR WAS 15 TO 30 SECONDS. THERE WAS ANOTHER INDIVIDUAL (FEMALE OPERATOR OF STERILIZER) AND THIS SUBJECT WAS REPORTED UNDER 2110898-2014-00003. THIS REPORT INCLUDES MORE INFO CONCERNING THE ACTUAL EVENT AND SERVICE INFO. THIS REPORT ONLY COVERS THE MALE SUBJECT REGARDING HIS EXPOSURE.