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

Catalog Number 10033

Device Problem Environmental Particulates (2930)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to customer site.The catalytic decomp filter, oil mist filter and vacuum pump oil was replaced to resolve the haze/mist/vapor issue.Unit meets specifications and was returned to service on (b)(6) 2015.

Event Description

A customer reported an event of a "mist/oil/cloud" (haze/mist/vapor) emitting from the sterrad nx sterilizer.There was no report of any injuries or human reactions.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.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), service history, failure mode and effects analysis (fmea), and system risk analysis (sra).The dhr was reviewed.The unit met manufacturing specifications at the time of release and there were no issues related to this failure mode noted.The service history for this unit was reviewed for the past 6 months (06/07/2015 to 12/04/2015) and trending was not exceeded.The fmea revealed the risk priority number (rpn) scores are considered to be acceptable.The sra shows the risk for exposure to toxic or corrosive material to be "low." the catalytic converter and pm level 1 kit was not returned for functional evaluation.The assignable cause of the odor/smells issue is the catalytic converter and pm level 1 kit.The field service engineer replaced these parts and confirmed the sterrad® nx was restored to proper function after service.The reported issue was resolved at the customer facility.The issue will be tracked and trended.

• Brand Name: STERRAD NX STERILIZER
• Type of Device: STERRAD EQUIPMENT (MLR)
• 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: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 5322867
• MDR Text Key: 34274333
• Report Number: 2084725-2015-00606
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10033
• Other Device ID Number: 10033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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