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

Catalog Number 10033

Device Problems Device Emits Odor (1425); Environmental Particulates (2930)

Patient Problem Skin Irritation (2076)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site on 12/15/2017 and confirmed the odor/smells/haze issue.Preventative maintenance was performed on the unit.The vacuum pump, catalytic converter and oil mist filter were replaced to resolve the odor/smells/haze issue.Unit meets specifications and was returned to service.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.Initial reporter phone #: (b)(6).Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of "odor and haze" emitting from their sterrad® nx sterilizer.The customer described it as a "bad smell" and ¿h202 residuals¿ coming from the sterilizer.Multiple healthcare workers (hcw¿s) also complained of throat and eye irritation and one hcw complained of a skin irritation while handling the load from a completed cycle.The hcw¿s symptoms were not considered serious as none of the hcws received any medical attention and the symptoms resolved on their own.Advanced sterilization products (asp) advised the customer their sterilizer was overdue for preventative maintenance and was advised to not use until this was completed.In addition, they were provided a quote for service and the customer opted not to repair the unit for several months.This event is being reported as a malfunction event subsequent to a serious injury.

Manufacturer Narrative

An advanced sterilization products (asp) account manager (am) visited the customer site and found that the material processed in the sterrad was for single use and not validated to be processed in the unit.The tyvek pouches were also not correctly sorted in the chamber as the mylar sides were facing each other.The am processed a test cycle using the same methods as the customer to simulate the issue.The cycle completed and there were no droplets of h2o2 but there were two white stains on the pouch.The asp account manager retrained the customer on proper instrument selection, packaging and positioning within the chamber of the unit as well as the importance of wearing proper personal protective equipment (ppe) while operating the unit.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells/haze issue and system risk analysis (sra).Trending analysis of the odor/smells/haze issue was reviewed from may 2017 to november 2017 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for return and further analysis.The assignable cause of the odor/smells/haze issue is likely due to the oil mist filter, catalytic converter 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.

• Brand Name: STERRAD® NX STERILIZER
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine 92618
• MDR Report Key: 7184193
• MDR Text Key: 97074536
• Report Number: 2084725-2018-00509
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• PMA/PMN Number: K042116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 10033
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0744-0746-2014
• Patient Sequence Number: 1