MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER ALLCLEAR 2-DR DUO; STERRAD® EQUIPMENT

Model Number	10104-008
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Skin Irritation (2076); No Code Available (3191)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The field service engineer noticed the screw to the oil mist filter had become loose and tightened it to resolve the haze/mist issue.Unit meets specifications and was returned to service.(b)(4).
Event or Problem Description
A customer reported an event of an odorless "mist" or haze emitting from the sterrad® 100nx sterilizer for approximately two days.Two healthcare workers (hcw¿s) experienced reactions of nausea, throat irritation, coughing, headache and cold hands.One healthcare worker who has a history of asthma reported respiratory symptoms; however, the symptoms resolved with their asthma inhaler.The hcw also reported a very slight "nose bleed." the hcws did not seek or receive any medical attention/treatment and the symptoms resolved with over-the-counter medications.Both hcws are reported to be good and both are back at work.The event was initially reported to the facility engineer on onsite on 6/17/2020, and the facility engineer said it was only steam and advised the hcws to continue working.The following day the facility contacted asp, and the customer was advised to turn the unit off and leave the room.An asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist 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 haze/mist issue was reviewed for the sterrad unit for the prior six months and no significant trend was observed.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were replaced to resolve the reported issue.The assignable cause of the haze/mist/vapor issue is likely due to a loose oil mist filter screw.The field service engineer tightened the screw 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.Asp complaint ref #: cmp(b)(4).

• Brand Name: STERRAD 100NX STERILIZER ALLCLEAR 2-DR DUO
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10267625
• Report Number: 2084725-2020-50137
• Device Sequence Number: 9817903
• Product Code: MLR
• UDI-Device Identifier: 10705037048700
• UDI-Public: 10705037048700
• Combination Product (Y/N): N
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10104-008
• Device Catalogue Number: 10104-008
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1