MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® NX ALLCLEAR; STERRAD® EQUIPMENT

Catalog Number	10033004
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A customer reported an event of a "oil mist filter failure" or haze/mist emitting from the sterrad® nx sterilizer.There was no report of any injuries or human reactions.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
The dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.(b)(4).
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.No haze/mist or smoke was observed.The vacuum pump oil, catalytic converter and oil mist filter were replaced to resolve the oil mist filter issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
It was incorrectly reported that the vacuum pump oil, catalytic converter and oil mist filter were replaced to resolve the oil mist filter failure issue.Instead, the oil return valve, vacuum control valve, and vacuum pump oil were replaced to resolve the oil mist filter failure issue.Unit meets specifications and was returned to service.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the oil mist filter failure issue, and system risk analysis (sra).Trending analysis of the oil mist filter failure issue was reviewed within the past six months and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the parts were not available for return and further analysis.The assignable cause of the oil mist filter failure issue is the oil return valve, vacuum control valve, and vacuum pump oil.The field service engineer replaced these parts and confirmed the sterrad® nx 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 #: (b)(4).

• Brand Name: STERRAD® NX ALLCLEAR
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8113084
• Report Number: 2084725-2018-00769
• Device Sequence Number: 2261909
• Product Code: MLR
• UDI-Device Identifier: 10705037048656
• UDI-Public: 10705037048656
• Combination Product (Y/N): N
• PMA/510(K) Number: K042116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2018

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 Catalogue Number: 10033004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 03/11/2019; 06/10/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/18/2018; 04/02/2019; 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1