3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1D

Additional Manufacturer Narrative

H10: THE STERILIZER WAS EXAMINED AND NO ISSUES WERE FOUND. THE 3M STERI-GAS EO CARTRIDGE LIKELY HAD A PRECONDITIONING FAILURE IN THE STERILIZER. THIS CARTRIDGE FAILURE RESULTED IN AN ERROR ON THE STERILIZER, AND ETHYLENE OXIDE WAS IN THE STERILIZATION CHAMBER WITHOUT THE CARTRIDGE HAVING BEEN PUNCTURED. 3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1D2 IS AN INDUSTRIAL DESIGN THAT IS NOT REGULATED AS A MEDICAL DEVICE. THIS REPORT WAS RECEIVED FROM AN INDUSTRIAL CUSTOMER AND NOT FROM A HEALTHCARE FACILITY.

Additional Manufacturer Narrative

PATIENT IDENTIFIER, WEIGHT, ETHNICITY, RACE: NOT PROVIDED. THE STERILIZER WAS EXAMINED AND NO ISSUES WERE FOUND. THE 3M STERI-GAS EO CARTRIDGE LIKELY HAD A PRECONDITIONING FAILURE IN THE STERILIZER. THIS CARTRIDGE FAILURE RESULTED IN AN ERROR ON THE STERILIZER, AND ETHYLENE OXIDE WAS IN THE STERILIZATION CHAMBER WITHOUT THE CARTRIDGE HAVING BEEN PUNCTURED.

Description of Event or Problem

A LABORATORY EMPLOYEE EXPERIENCED LIGHTHEADEDNESS AND HEADACHE AFTER ALLEGED EXPOSURE TO ETHYLENE OXIDE FROM A 3M STERI-GAS EO CARTRIDGE THAT OCCURRED AFTER A 3M STERI-VAC STERILIZER, 1 DOOR GS8X-1D DOOR WAS OPENED. AN ERROR MESSAGE APPEARED ON THE STERILIZER (E108) THE NEXT MORNING AFTER THE STERILIZER RAN OVERNIGHT AND AN EMPLOYEE OPENED THE STERILIZER DOOR. AN ETHYLENE OXIDE ALARM SOUNDED. THE EMPLOYEE WAS SENT TO URGENT CARE, WHERE VITAL SIGNS WERE CHECKED AND FOUND TO BE NORMAL. NO MEDICATION OR OTHER TREATMENT WAS PROVIDED. A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR THE FOLLOWING DAY AND THE SYMPTOMS HAD SUBSIDED. NO ISSUES WERE FOUND WITH THE STERILIZER.