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

Model Number 10104-003

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the smoke/haze and odor/smells issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of a smoke/haze and odor/smell emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer was advised to discontinue use of the unit and avoid working in the room until the unit was serviced.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

The device history record (dhr) was reviewed for the sterrad® unit and no anomalies were observed that would contribute to the reported issue at the time of release.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Correction to investigation results: an asp fse was dispatched to the customer site.The fse was unable to identify any oil mist but instead identified odor.In addition, the asp fse stated the customer was using a third-party catalytic converter.The pm kit was used to replace the adapter converter, catalytic converter, oil mist filter, vacuum pump oil.The fse confirmed the unit met specifications.System was returned to service.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze and odor/smells issue, and system risk analysis (sra).Trending analysis of the smoke/haze and odor/smells issue for the sterrad 100nx sterilizer was reviewed for the previous six months from open date and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." functional analysis was not performed as the customer was using a non-asp part and the other asp parts were not returned.The assignable cause of the smoke/haze and odor/smells issue is the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil.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.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze and odor/smells issue, and system risk analysis (sra).¿trending analysis of the smoke/haze and odor/smells 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 smoke/haze and odor/smells issue is the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil.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.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100NX STERILIZER 1-DR W/ DUO
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 9624917
• MDR Text Key: 180899297
• Report Number: 2084725-2020-50000
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037047581
• UDI-Public: 10705037047581
• 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,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10104-003
• Device Catalogue Number: 10104003
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1026-1027-2013
• Patient Sequence Number: 1