MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD NX STERILIZER; STERRAD EQUIPMENT

Model Number 10033

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Upon follow-up, the biomed at the facility confirmed he replaced the vacuum pump to resolve the smoke/haze issue and the unit was returned to service and meets specifications the dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).

Event Description

A trained biomed at the facility reported an event of smoke or haze emitting from their sterrad® nx sterilizer.There was no report of any injuries or human reactions.The biomed was advised to turn the unit off and leave the room.The biomed stated he has ordered the necessary parts to do the repair.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue and system risk analysis (sra).Trending analysis of the smoke/haze issue for the sterrad® nx unit was reviewed for the prior six months from open date and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the vacuum pump was not returned for further evaluation.The assignable cause of the smoke/haze is likely due to the vacuum pump.The trained biomed replaced the part and confirmed the sterrad® nx 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).

• Brand Name: STERRAD NX STERILIZER
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 11283225
• MDR Text Key: 231406534
• Report Number: 2084725-2020-50213
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014132
• UDI-Public: 10705037014132
• Combination Product (y/n): N
• PMA/PMN Number: K042116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10033
• Device Catalogue Number: 10033
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1