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

Catalog Number 10101

Device Problem Device Emits Odor (1425)

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

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

An asp field service engineer was dispatched to assess the unit onsite and identified that the fan assembly was put on backwards by a non-asp engineer.The asp fse adjusted the fan assembly to the correct orientation to resolve the odor/smells issue.However, the fse was unable to confirm the unit meets specifications since the customer was using several third-party parts.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).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 odor/smells 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." no parts were replaced as a result of this issue.The assignable cause of the odor/smells issue is the fan assembly.The field service engineer adjusted the fan assembly in the correct orientation.However, the fse was unable to confirm the sterrad® 100s was restored to proper function since the customer was using several third-party parts in their unit.A quote was provided to the customer for asp parts with a recommendation to avoid use of the until it is in compliance with manufacturer specifications.The customer was sent a letter to address the unit not meeting manufacturer specifications.Asp will continue to track and trend this issue.(b)(4).

Event Description

A customer reported two healthcare workers (hcws) experienced respiratory and neurological reactions while working around their sterrad ® 100s sterilizer that was emitting a harsh odor and blowing air from the chamber of the sterrad® sterilizer for three months.It was also reported the sterrad® was being maintained and serviced by a non-asp service engineer.This report is for healthcare worker # 2 who experienced symptoms of headaches, cough, throat irritation, and a bitter taste in the mouth and hoarseness in her voice when she breathed in the fumes.She was seen in occupational medicine at the facility and was given pepcid and prescribed prednisone orally.She was referred to the ear-nose-throat specialist since her throat irritation persist, but is reported to be "ok, just a little tired." she has continued to work in the department the entire time.The customer was advised to refrain using the unit, evacuate the area until the odor was no longer present and ventilate the room per facility standards.An asp field service engineer was dispatched to assess the unit onsite.Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable as a serious injury.(b)(4) and (b)(4) are related complaints from the same facility.This is one of two 3500a reports being submitted for this event.Please reference manufacturer report numbers: 2084725-2019-00972 and 2084725-2019-00974.

• Brand Name: STERRAD® 100S STERILIZER
• 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 ; 949453-639
• MDR Report Key: 9239855
• MDR Text Key: 167407046
• Report Number: 2084725-2019-00974
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014460
• UDI-Public: 10705037014460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/25/2019
• Date Device Manufactured: 07/11/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0744-0746-2014
• Patient Sequence Number: 1
• Patient Age: 39 YR