MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100S STERILIZER; STERRAD® EQUIPMENT

Catalog Number	10101
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Itching Sensation (1943); Burning Sensation (2146)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A field service engineer was dispatched to the customer site.The vacuum pump oil, catalytic converter and oil mist filter were replaced 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 100s sterilizer.Two healthcare workers (hcw¿s) experienced a reaction or discomfort of throat irritation and skin irritation.The hcw's did not seek or receive any medical attention/treatment and both healthcare workers are now reported to be ¿without discomfort." 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 hcw¿s symptoms suggest the event was not serious.The hcw¿s did not receive medical attention, and there is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure; however, this event is being reported as a malfunction subsequent to a serious injury.
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 evaluation.The assignable cause of the odor/smells issue is likely due to the catalytic converter, oil mist filter and vacuum pump oil.The field service engineer replaced the parts and confirmed the sterrad 100s 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® 100S STERILIZER
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7864643
• Report Number: 2084725-2018-00701
• Device Sequence Number: 2472708
• Product Code: MLR
• UDI-Device Identifier: 10705037014460
• UDI-Public: 10705037014460
• Combination Product (Y/N): N
• PMA/510(K) Number: K991999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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-0744-0746-2014
• Patient Sequence Number: 1