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

Catalog Number 10033

Device Problem Chemical Problem (2893)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to customer site.The catalytic decomp filter was replaced to resolve the haze/mist/vapor issue.Unit meets specifications and was returned to service on 11/13/2015.

Event Description

A customer reported an event of a "haze" emitting from the sterrad nx sterilizer when it is running.No odor is detected.There was no report of 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.(b)(4) are related complaints from the same facility.This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2015-00567 and 2084725-2015-00568.

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 (05/16/2015 to 11/12/2015) 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 was not returned for functional evaluation.The assignable cause of the haze/mist/vapor is the catalytic converter.The field service engineer replaced this part 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: 5278024
• MDR Text Key: 33038528
• Report Number: 2084725-2015-00568
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

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: 10033
• Other Device ID Number: 10033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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