MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER ALLCLEAR 1-DR DUO; STERRAD® EQUIPMENT

Catalog Number 10104007

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)

Event Date 05/24/2019

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, 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® 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of odor and haze emitting from their sterrad® 100nx sterilizer.One healthcare worker (hcw) reported he experienced burning eyes, sore throat and itchy skin related to the odor and haze emitting from the sterrad®.The hcw reported his symptoms occurred for two hours after exposure.The hcw did not report he received medical attention and reported to be ¿ok¿.The customer was advised to turn the unit off and leave the room.An asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a serious injury.

• Brand Name: STERRAD® 100NX STERILIZER ALLCLEAR 1-DR DUO
• 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: 8707906
• MDR Text Key: 148305614
• Report Number: 2084725-2019-00884
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10104007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2018
• 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-1026-1027-2013
• Patient Sequence Number: 1