MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER W/DUO; STERRAD® EQUIPMENT

Catalog Number	10104003
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Headache (1880); Skin Irritation (2076); Burning Sensation (2146)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The fse reported the unit was not under a service contract and preventative maintenance was overdue.The fse performed preventative maintenance on the unit and replaced the catalytic converter, oil mist filter and vacuum pump oil to resolve the odor/smells issue.Unit meets specifications and was returned to service.(b)(4).
Event or Problem Description
A customer reported an event of an ¿odor" or smell emitting from the sterrad® 100nx sterilizer while the unit was running.One healthcare worker (hcw) experienced a headache and red blotches/hives on both arms and back and complained of a little forehead swelling too.The hcw did not have any respiratory symptoms or trouble breathing.However, it was reported the hcw went to occupational health (oh) because of the skin reaction and was given a steroid injection, tetanus shot, and prescribed a ¿z-pac¿ to take at home.The hcw reported the clinician in oh said it was possible she might have had an allergic reaction to vapor.The symptoms resolved completely the following day and the hcw stated she is ¿fine.¿ regarding the sterrad® 100nx sterilizer, the customer was advised to power off the unit and leave the room.A field service engineer (fse) was dispatched to the customer site.The hcw continues to work in ¿close proximity¿ to the sterrad® 100nx sterilizer, but she has had no other reactions since service on the unit was completed.Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable as a serious injury.Although the hcw is reported to be fine and her symptoms completely resolved, she received medical treatment and medication for a skin reaction and possible allergic reaction to odor from a sterrad® 100nx sterilizer.Furthermore, this event is being reported as a malfunction subsequent to a previous serious injury for odor.
Additional Manufacturer Narrative
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 from (b)(6) 2018 to (b)(6) 2018 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for return and further analysis.The assignable cause of the odor/smells issue is likely due to the oil mist filter, catalytic converter and vacuum pump oil.The field service engineer replaced these parts 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.(b)(4).

• Brand Name: STERRAD® 100NX STERILIZER W/DUO
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7976205
• Report Number: 2084725-2018-00732
• Device Sequence Number: 17601241
• Product Code: MLR
• UDI-Device Identifier: 10705037047581
• UDI-Public: 10705037047581
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10104003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1026-1027-2013
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other