3M STERI-VAC ETHYLENE STERILIZER/AERATOR

Additional Manufacturer Narrative

THE REPORT PERTAINS TO A MALFUNCTION OF THE DEVICE. THIS TYPE OF FAILURE WOULD ALWAYS RESULT IN AN AUDIBLE SOUND. THE DEFECTIVE PART INVOLVED IN THIS INCIDENT IS NO LONGER USED IN MANUFACTURING AND WAS REPLACE DIN LATE 2007 WITH A NEW PART. THE NEW PART'S BRASS BUSHING AND SEAL IS SECURELY FASTENED ONTO THE MATING POCKET OF THE CYLINDER. 3M CONTINUES TO INVESTIGATE THE FAILED PART AND RELATED EVENT TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED. ANY ADDITIONAL ACTIONS AND FINDINGS WEILL BE SHARED WITH FDA UNDER A SUPPLEMENTAL REPORT TO THIS INITIAL REPORT. THE UNIT INVOLVED IN THIS EVENT WAS NOT RETURNED TO THE COMPANY. THE DEFECTIVE PART WAS REPLACED WITH THE NEW PART (IMPLEMENTED IN LATE 2007) PERFORMED UNDER A SERVICE REPAIR WHICH TOOK PLACE WITHIN THE HOSPITAL FACILITY.

Description of Event or Problem

DURING ROUTINE OPERATION, IT WAS REPORTED THAT AN 8XL 3M STERI-VAC ETHYLENE STERILIZER DISPLAYED AN ERROR CODE (E71) THAT TRIGGERED THE UNIT'S AUDIBLE ALARM. SIMULTANEOUSLY WITH THIS ALARM THE USER'S PROVIDED EO MONITOR SOUNDED INDICATING THE PRESENCE OF EO WITHIN THE OPERATORS ROOM. THE INDIVIDUALS WITHIN THE ROOM LEFT IMMEDIATELY RESULTING IN NO REPORTED INJURY OR EO EXPOSURE.