MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX ALLCLEAR 1-DR DUO; STERRAD® EQUIPMENT

Catalog Number	10104-007
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Codes	Burn(s) (1757); Itching Sensation (1943); Skin Irritation (2076)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The oil mist filter assembly and catalytic converter were replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.Asp complaint #: (b)(4).
Event or Problem Description
A customer reported a healthcare worker (hcw) experienced throat irritation and hives related to a smoke/mist emitting from their sterrad® 100nx all clear sterilizer.The hcw reported the fire department was called when smoke was observed in the sterile processing room.The hcw remained in the room for approximately an hour before it was determined that it was not smoke but instead it was a mist/haze coming from the back of the sterrad® 100nx unit.A field service engineer (fse) was dispatched to the site to assess the unit.Regarding the hcw¿s symptoms, it was reported her throat was sore and she lost her voice.She also stated she had two spots on her neck that she described as small water blisters which she believes were in areas that were exposed and possibly made contact with the mist.The healthcare worker went to the emergency room and was treated with a ¿liquid steroid¿ (dexamethasone) for irritated mucous membranes.A chest x-ray was done and the result was normal.The hcw reported the two spots on her neck cleared up later that day.When asked about her current status, the hcw reported she thought she might have a sinus infection because her throat is still irritated, although she stated she has ¿no fever and feels fine¿.Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable.The hcw experienced a skin and respiratory reaction, and although it was reported the skin reaction resolved and she ¿feels fine¿, the hcw received medical attention and was given a steroid for respiratory inflammation.
Additional Manufacturer Narrative
The investigation included a review of the device history record (dhr), trending analysis of the smoke/haze/mist issue, trending analysis of the human reaction issue and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the smoke/haze/mist issue was reviewed from august 2017 to february 2018 and no significant trend was observed.Trending analysis of the human reaction issue was reviewed from august 2017 to february 2018 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for return and further analysis as they were contaminated with oil.The assignable cause of the smoke/haze/mist issue which lead to the human reaction is likely due to the catalytic converter and oil mist filter.The field service engineer replaced these parts and confirmed the sterrad 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.

• Brand Name: STERRAD® 100NX ALLCLEAR 1-DR DUO
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7311463
• Report Number: 2084725-2018-00539
• Device Sequence Number: 10178155
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K160903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10104-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1