3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATOR
Received Jan 4, 2019 · Event occurred Dec 6, 2018
Report 2110898-2019-00002 · MDR key 8219436
Device
Product problems
- Electrical /Electronic Property Problem
- Overheating of Device
- Failure to Sense
- Device Sensing Problem
- Temperature Problem
- Electrical /Electronic Property Problem
- Overheating of Device
- Failure to Sense
- Device Sensing Problem
- Temperature Problem
Patient
46 YR
- Headache
- Itching Sensation
- Chemical Exposure
- Headache
- Itching Sensation
- Chemical Exposure
Narrative
Additional Manufacturer Narrative
DEVICE IS UNDER INVESTIGATION. INITIAL ANALYSIS BY SERVICE ENGINEERS INDICATES OVER-TEMPERATURE CONDITION. COMPONENTS HAVE BEEN REQUESTED FOR ADDITIONAL ANALYSIS AND ROOT CAUSE DETERMINATION. THE STERILIZER WAS MANUFACTURED IN YEAR 2005. THIS MDR REPRESENTS PATIENT 1; EMDR 2110898-2019-00003 REPRESENTS PATIENT 2. END OF REPORT.
Description of Event or Problem
A (B)(6) FEMALE EMPLOYEE ALLEGED THAT SHE EXPERIENCED PERIORAL ITCHING AND AN INTENSE HEADACHE AFTER A 3M¿ STERI-VAC¿ 8XL STERILIZER/AERATOR (SERIAL NUMBER (B)(4)) CHAMBER WAS OPENED AND A 3M¿ STERI-GAS ETHYLENE OXIDE CARTRIDGE WAS FOUND TO BE BROKEN. THE USERS AT THE HOSPITAL REPORTED THAT THE STERILIZED MATERIAL AND THE INSIDE OF THE CHAMBER WERE VERY HOT. THE PATIENT SAW A NURSE FOR THE SYMPTOMS AND NO TREATMENT WAS PROVIDED. THE SYMPTOMS SUBSIDED.
Additional Manufacturer Narrative
SUSPECT COMPONENTS WERE RETURNED FOR ANALYSIS. ANALYSIS WAS PERFORMED AND FAILURE COULD NOT BE REPLICATED. ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, INITIAL ANALYSIS IS STILL VALID THAT INDICATED THAT AN OVER-TEMPERATURE CONDITION OCCURRED. THIS IS AN ISOLATED EVENT, WHERE MULTIPLE FAILURES OCCURRED. THE OCCURRENCE OF MULTIPLE FAILURES IS REMOTE. THE STERILIZER WAS REPAIRED AND BROUGHT BACK INTO SERVICE. THE STERILIZER WAS MANUFACTURED IN YEAR 2005. THIS EMDR REPRESENTS PATIENT 1; EMDR 2110898-2019-00003 REPRESENTS PATIENT 2.