MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER 2-DR; STERRAD® EQUIPMENT

Model Number	10104-002
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Dyspnea (1816); Itching Sensation (1943); Rash (2033); Sore Throat (2396)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an event of an ¿odor¿ or smell emitting from the sterrad® 100nx sterilizer.It was reported that five health care workers (hcws) detected the odor and experienced minor respiratory and/or skin reactions.All five hcws exhibited symptoms of red, itchy rash over the ¿whole body¿.It was reported that all five hcws wore ppe of masks, gowns, and gloves, and they evacuated the room to help resolve the symptoms.Hcw1 was unloading from the sterilizer¿s chamber and experienced an additional ailment of dysphonia; the dysphonia resolved in 8 hours and the rash with eruptions resolved in 24 hours, and no medical treatment was reported.Hcw2 experienced breathing difficulty and a rash with papules; the breathing difficulty resolved in 6 hours and the rash resolved in 24 hours with no medical treatment reported.The remaining three hcws only experienced the skin reaction of rash with eruptions; however, the condition lasted 5 days and was treated with an over-the-counter (otc) oral antihistamine loratadine.Lastly, all five hcws were reported to have recovered.An asp field service engineer was dispatched to assess the unit onsite.The information suggests the respiratory and skin reactions were not serious and resolved with no or minimal medical treatment.However, this event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).A field service engineer was dispatched to the customer site.The catalytic converter and oil mist filter were replaced to resolve the odor/smell issue.Unit meets specifications and was returned to service.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Correction: per the secondary review of this event, it was discovered that hcw2 was incorrectly referenced in block b5 of the initial medwatch report.Hcw5 was the personnel who exhibited the reported minor symptoms.Corrected statement is as follows: ¿hcw5 experienced breathing difficulty and a rash with papules; the breathing difficulty resolved in 6 hours and the rash resolved in 24 hours with no medical treatment reported.¿ h3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smell issue, and system risk analysis (sra).The device history record (dhr) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the odor/smell 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." no parts were available for further analysis.The assignable cause of the odor/smell is likely due to the catalytic converter and oil mist filter.The asp field service engineer replaced the 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.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX STERILIZER 2-DR
• 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: 13911559
• Report Number: 2084725-2022-00066
• Device Sequence Number: 4276816
• Product Code: MLR
• UDI-Device Identifier: 10705037014507
• UDI-Public: 10705037014507
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 10104-002
• Device Catalogue Number: 10104-002
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• 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