3M STERI-VAC 8XL STERILIZER/AERATOR
Received Aug 12, 2011 · Event occurred Jul 16, 2011
Report 2110898-2011-00106 · MDR key 2218358
Device
Generic name
880.6860 Sterilizer, Ethylene-oxide Gas
Manufacturer
3m Health CareModel number
NACatalog number
8XL
Lot number
45078
Product problems
- Device Alarm System
- Improper or Incorrect Procedure or Method
Patient
NK
- Radiation Exposure, Unintended
Narrative
Description of Event or Problem
3M REC'D INFO FROM A CUSTOMER THAT REPORTED DURING A CHEMDAC MONITORING CYCLE THE ALARM SOUNDED. NO ONE WAS IN THE ROOM BUT AN EMPLOYEE RAN INTO THE ROOM AND PLACED A BADGE ON THE 3M STERI-VAC 8XL STERILIZER/AERATOR. REPORTEDLY, THE STAFF AERATED UNTIL THE NEXT DAY AND THEN ENTERED THE ROOM WITH THE STERILIZER. IT WAS REPORTED THEY DID NOT HAVE AN OVEREXPOSURE OF ETHYLENE OXIDE (EO) PER (B)(4) LIMITS, HOWEVER, THEY DID HAVE AN EO EXPOSURE WHEN THE EMPLOYEE PUT THE BADGE ON THE MACHINE. THE BADGE READ 7.99 PPM IN A 30 MIN SAMPLING TIME BUT THE PERSON WAS NOT WEARING THE BADGE THAT ENTIRE TIME AND THERE WERE NO REPORTED SYMPTOMS.
Additional Manufacturer Narrative
NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADD'L INFO IS REC'D, A F/U REPORT WILL BE SUBMITTED. NO EVAL WILL BE PERFORMED.
Remedial action
- Other