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

Model Number 10104-007

Device Problem Smoking (1585)

Patient Problems Headache (1880); No Code Available (3191)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of an odorless vapor/smoke emitting from the sterrad® 100nx sterilizer and one healthcare worker (hcw) experienced irritation, burning, and itchiness in the eye.Upon follow-up, the hcw noted he took his contacts off to rinse and flush his eyes, and the reaction lasted 4 hours.The hcw also had a ¿light headache¿ which lasted 1 hour.However, the hcw did not receive medical attention/treatment for his symptoms.The customer was advised to clear the facility and shut down the unit until serviced.An asp field service engineer was dispatched to assess the unit onsite.The injuries reported were not considered serious as the symptoms resolved on their own without any medical treatment.However, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/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 smoke/haze 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 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 ALLCLEAR 1-DR DUO
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 9578279
• MDR Text Key: 178966231
• Report Number: 2084725-2019-00010
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 10104007
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1