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

Catalog Number 10033

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.Haze/mist/vapor was confirmed.A corrective maintenance was performed and the vacuum pump oil was replaced.Unit meets specifications and was returned to service on (b)(6) 2015.

Event Description

A customer reported an event of a "smoke/haze" emitting from the sterrad® nx sterilizer.There was no report of any injuries or human reactions.The customer was advised to turn the unit off and evacuate the area until the haze dissipates.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, trending of the product malfunction code, 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 for the past six months (03/28/2015 to 09/24/2015) did not observe any significant trend.The trend for the product malfunction code of haze/mist/vapor was completed from (b)(6) 2014 through (b)(6) 2015 and did not reveal a significant trend.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." no parts were returned for further evaluation.The assignable cause of the haze/mist/vapor issue is the vacuum pump oil.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: 5164627
• MDR Text Key: 29083350
• Report Number: 2084725-2015-00466
• 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: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• 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: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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