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

Model Number 10104-007

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The oil mist filter was replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of an "oil mist" emitting from the sterrad® 100nx sterilizer when the vacuum pump was operating.There was no report of any injuries or human reactions.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.

Manufacturer Narrative

D10: device available for evaluation: correction from no to yes.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist issue, system risk analysis (sra) and functional analysis.Trending analysis of the haze/mist issue for the sterrad® 100nx unit 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 oil mist filter was returned and tested.Visual inspection yielded no unusual findings or anomalies.The test cycle successfully completed with no failures.There was no mist/haze observed.The reason for the return could not be confirmed.The assignable cause of the haze/mist issue is likely due to the oil mist filter.The field service engineer replaced this part 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 #: (b)(4).

• Brand Name: STERRAD 100NX ALLCLEAR 1-DR DUO
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10775115
• MDR Text Key: 221288926
• Report Number: 2084725-2020-50258
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• Combination Product (y/n): N
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10104-007
• Device Catalogue Number: 10104-007
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1