MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX ALLCLEAR STERILIZER 2-DR; STERRAD® EQUIPMENT

Model Number 10104-006

Device Problem Device Emits Odor (1425)

Patient Problems Itching Sensation (1943); Eye Burn (2523); Unspecified Respiratory Problem (4464); Skin Burning Sensation (4540)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

A customer reported an event of a ¿strong odor¿ or smell emitting from the sterrad® 100nx sterilizer, and health care workers (hcws) reported experiencing respiratory and skin reactions that they attributed to ¿peroxide¿ when handling the load at the end of the sterilization cycle.The symptoms were described as itching and ¿burning¿ on arms and face, reddened eyebrows, and irritation in the throat and dry mouth with a ¿burning¿ sensation.The customer stated that the hcws were instructed to leave the room when not in use.An asp field service engineer was dispatched to assess the unit onsite.The customer did not specify how many hcws were affected, and no medical or surgical intervention was reported.Based on the information available at the time of this report, the hcws symptoms were assessed as minor injuries; however, this event is being reported as a malfunction report subsequent to a previous serious injury for odor/smells issue.

Manufacturer Narrative

Initial reporter zip code: (b)(6).A field service engineer was dispatched to the customer site.The sterrad® 100nx sterilizer was relocated to optimize airflow, and the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the odor/smells issue.Unit meets specifications and was returned to service.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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

Date of event was updated to 15-nov-2022.Additional event information specified that seven female health care workers (hcws) experienced minor reactions associated with the reported event that started on 15-nov-2022.It was reported that no medical attention or treatment was received, and that all the hcws have recovered.The hcws were retrained on the appropriate procedure as per the sterrad® 100nx user¿s guide and were informed to always wear gloves when working with the system.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 issue, and system risk analysis (sra).¿ trending analysis of the odor/smells issue 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." no parts were available for further analysis.The assignable cause of the odor/smell is potentially due to the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil.The asp field service engineer replaced the parts and confirmed the sterrad® 100nx met functional specifications 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 ALLCLEAR STERILIZER 2-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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 16057398
• MDR Text Key: 308540919
• Report Number: 2084725-2022-00357
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2023

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 Model Number: 10104-006
• Device Catalogue Number: 10104-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/04/2023; 07/21/2023
• Supplement Dates FDA Received: 01/26/2023; 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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