MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER1-DR; STERRAD® EQUIPMENT

Catalog Number 10104

Device Problem Device Emits Odor (1425)

Patient Problems Headache (1880); Nausea (1970)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The male connector tube was replaced to resolve the odor/smells issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of a "oily smell" or odor emitting from the sterrad® 100nx sterilizer.One healthcare worker (hcw) experienced a reaction of nausea and an unconfirmed number of hcws experienced headaches.None of the hcws needed medical treatment for their symptoms.The customer was advised discontinue usage of unit and evacuate area until the odor was no longer present.An asp field service engineer was dispatched to assess the unit onsite.Based on the information received in the complaint at the time the reporting determination was made, the hcws¿ symptoms suggests the event was not serious.However, this event is being reported as a malfunction subsequent to a serious injury for the report of odor/smell.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells issue, 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 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 part was not available for return since it was saturated in oil.The assignable cause of the odor/smells issue is the male connector tube.The field service engineer replaced this part 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).

• Brand Name: STERRAD® 100NX STERILIZER1-DR
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9147364
• MDR Text Key: 176073883
• Report Number: 2084725-2019-00955
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (y/n): N
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: 10104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1026-1027-2013
• Patient Sequence Number: 1