STERI-VAC 8XL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-19 for STERI-VAC 8XL * manufactured by 3m Company.

Event Text Entries

[22122944] When ethylene oxide was exhausted from 3m steri-vac sterilizer to the abator, ethylene oxide gas sensors detected ethylene oxide gas in the room that housed the sterilizers. Subsequent investigation by 3m field maintenance and clinic's facilities maintenance, determined that a valve on an adjacent sterilizer leaked a test gas. The gas exhaust for these two adjacent sterilizers are on the same discharge line. It was then determined by 3m field maintenance that this valve was not the one specified for that location within the sterilizer and that this improper valve was likely the cause of the ethylene oxide leaks. We are concerned about ethylene oxide exposure to healthcare workers as a result of this problem. There was no patient involved with the device. ====================== manufacturer response for ethylene oxide sterilizer, 3m steri-vac 8xl ethylene oxide sterilizer exhaust release (per site reporter)======================conference call was conducted recently between: 3m marketing management and engineering staff and facilities operations, maintenance, safety, and linen & central service operations. From the conference call: 1) the problem 3m 8xl sterilizer would be removed and replaced 2) 3m will identify a procedure to effectively pressure test the sterilizer exhaust system. 3) 3m will specify exhaust isolation valves and secondary check valves.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2175133
• MDR Report Key: 2175133
• Date Received: 2011-07-19
• Date of Report: 2011-07-19
• Date of Event: 2011-06-01
• Report Date: 2011-07-19
• Date Reported to FDA: 2011-07-19
• Date Added to Maude: 2011-07-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STERI-VAC 8XL
• Generic Name: STERILIZER, ETHYLENE-OXIDE GAS
• Product Code: FLF
• Date Received: 2011-07-19
• Model Number: *
• Catalog Number: 8XL
• Lot Number: *
• ID Number: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M COMPANY
• Manufacturer Address: * ST. PAUL MN 55144100 US 55144 1000

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-07-19