MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX 1-DR STERILIZER W/ DUO; STERRAD® EQUIPMENT

Model Number	10104-003
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Dizziness (2194)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The oil return solenoid valve was replaced to resolve the odor/smell issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A customer reported an event of an ¿odor¿ or smell emitting from the sterrad® 100nx sterilizer.Two female healthcare workers (hcws) experienced human reactions.One hcw felt sensitivity and experienced a headache, and the second hcw experienced shortness of breath and dizziness.Both hcws were ¿checked out¿ in occupational health and reported ¿ok¿ and ¿back to work.¿ advanced sterilization products has requested additional clinical follow-up related to this event, but has received nothing further to date.The customer was instructed to power the unit off and discontinue use.An asp field service engineer was dispatched to assess the unit onsite.Based on the information received to date, the information suggests the neurological and respiratory reactions were not serious.However, this event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
H3: 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 device history record (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 for the sterrad® 100nx unit was reviewed for the prior six months from open date and no significant trend was observed.¿review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the oil return solenoid valve was not returned for further evaluation.The assignable cause of the odor/smell is likely due to the oil return solenoid valve.The asp field service engineer replaced the 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 #: cmp-(b)(4).

• Brand Name: STERRAD® 100NX 1-DR STERILIZER W/ DUO
• Common Device Name: STERRAD® EQUIPMENT
• 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 12478081
• Report Number: 2084725-2021-00303
• Device Sequence Number: 10475150
• Product Code: MLR
• UDI-Device Identifier: 10705037047581
• UDI-Public: 10705037047581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Model Number: 10104-003
• Device Catalogue Number: 10104-003
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown