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

Catalog Number 10101

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

Patient Problems Headache (1880); Nausea (1970); No Code Available (3191)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the smoke/haze and odor/smells issue.Unit meets specifications and was returned to service.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze and 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 smoke/haze and 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." the parts were not available for return and further analysis.The assignable cause of the smoke/haze and odor/smells issue is the catalytic converter, oil mist filter, and vacuum pump oil.The field service engineer replaced these parts and confirmed the sterrad® 100s was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.(b)(4).

Event Description

A customer reported an event of smoke and a "strong chemical odor" emitting from the sterrad® 100s sterilizer.Two healthcare workers (hcw) experienced eye irritation and "slight burning", headache, and nausea.The hcws did not seek or receive medical attention or treatment for their symptoms.An asp field service engineer was dispatched to assess the unit onsite.The hcws eye, neurological and gastro-intestinal symptoms resolved without medical treatment.However, this event is being reported as a malfunction subsequent to a serious injury.

• 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: 9241009
• MDR Text Key: 176077609
• Report Number: 2084725-2019-00975
• 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: 10/08/2019

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: 10101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/25/2019
• Date Device Manufactured: 06/08/2002
• 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