MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER; STERRAD® EQUIPMENT

Model Number 10104

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported an event of a "mist" or haze emitting from the sterrad® 100100nx 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.

Manufacturer Narrative

The initial report incorrectly stated the oil mist filter, catalytic converter, adapter converter and vacuum pump oil were replaced to resolve the mist/haze issue.Instead, the oil mist filter and catalytic converter were replaced to resolve the mist/haze issue.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the mist/haze 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 mist/haze 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 parts were not available for return and further analysis.The assignable cause of the mist/haze issue is the oil mist filter and catalytic converter.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
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10227199
• MDR Text Key: 200025849
• Report Number: 2084725-2020-50124
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (y/n): N
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10104
• Device Catalogue Number: 10104
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1