MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER 100NX(TM) 1-DR; STERRAD® EQUIPMENT

Catalog Number 10104

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

Patient Problems Nausea (1970); Red Eye(s) (2038)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

A customer reported an event of an ¿odor¿ or smell and a ¿mist¿ or haze emitting from the sterrad® 100nx sterilizer, and three health care workers (hcws) reported experiencing eye irritation and upset stomach/nausea.The hcws rinsed their eyes at the eye-wash station to resolve the symptoms, and no required treatments were reported related to this event.Additional event information confirmed hcw1 did not require medical treatment, and hcw1 health status was reported as ¿ok." it was further noted that all three hcws continue to work in the department.The customer additionally reported that a third-party servicer (arjo) recently replaced a pump, and stated that the pump might not be a genuine asp part.It was further reported the technician replaced the pump again, but the odor/smells issue persisted.An asp field service engineer was dispatched to assess the unit onsite.There were no medical treatments reported associated with this event, and the reported symptoms were assessed to be minor injuries.However, this event is being reported as a malfunction report subsequent to a previous serious injury related to odor/smells and mist/haze issues.

Manufacturer Narrative

An asp field service engineer (fse) was dispatched to the customer site and identified the mist/haze was emitting from the catalytic converter.The fse noted the oil mist filter housing was crooked, and the oil mist filter appeared different.The fse confirmed there were non-asp parts installed, and noticed the unit has not been calibrated for at least two and a half years.The fse recommended a preventive/planned maintenance service for the sterrad® 100nx unit to help resolve the reported issues; however, the customer has not approved the recommended service, and the sterrad® 100nx system is not restored to manufacturer specifications.The customer was advised to discontinue using the unit until it is in compliance with manufacturer specifications.The device history record (dhr) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Advanced sterilization products will continue to follow up for additional information.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells and mist/haze issues, and system risk analysis (sra).¿ trending analysis of the odor/smells and mist/haze issues for the sterrad® 100nx unit was reviewed for the prior six months from the event date, and no significant trend was observed.¿ review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the fse confirmed there were non-asp parts installed; however, no parts were replaced as the customer has declined the recommended planned/preventive maintenance (pm) service.The assignable cause of the odor/smell and mist/haze is likely due to the non-asp parts installed.The asp field service engineer recommended the pm service to help resolve the reported issues; however, the customer has declined the service and the unit was not returned to specifications.The customer was recommended to avoid using the unit until it is in compliance with manufacturer specifications.As per the sterrad® 100nx user¿s guide: repairs and adjustments should only be attempted by experienced technicians who are fully trained to maintain and repair the sterrad® 100nx® sterilizer.Use of unauthorized parts for maintenance or repair could cause personal injury, result in costly damage, or sterilizer malfunction and voids the warranty.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX STERILIZER 100NX(TM) 1-DR
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 17749830
• MDR Text Key: 323775599
• Report Number: 2084725-2023-00253
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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: 10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1