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

Catalog Number 10033

Device Problem Device Emits Odor (1425)

Patient Problem Burning Sensation (2146)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

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.The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of a "strong odor" or smell emitting from the sterrad® nx sterilizer.A healthcare worker (hcw) experienced a skin reaction related to the odor and reported itching on her face when she opened the sterrad® door to remove the load after completion of the cycle.The hcw did not seek or receive any medical attention/treatment.An asp field service engineer was dispatched to assess the unit onsite.Based on the information received in the complaint, the hcw symptoms suggest the event was not serious and she did not require medical treatment.In addition, 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 for odor.

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).¿ trending analysis of the odor/smells issue was reviewed from december 2017 to june 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/smell 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® nx 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).

Manufacturer Narrative

At the time of submitting this report on september 04, 2018, section g6 was inadvertently selected as follow-up #2 in error.Therefore, this report is now being submitted as follow-up #1 to correct the error.The investigation has been reviewed, and there is no additional information to report for this event.

• Brand Name: STERRAD® NX STERILIZER
• Type of Device: 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: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7646507
• MDR Text Key: 112851808
• Report Number: 2084725-2018-00642
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014132
• UDI-Public: 10705037014132
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K042116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

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: 10033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 08/30/2018; Not provided
• Supplement Dates FDA Received: 10/26/2023; 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0744-0746-2014
• Patient Sequence Number: 1
• Patient Sex: Unknown