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

Model Number 10104-003

Device Problem Environmental Particulates (2930)

Patient Problems Dyspnea (1816); Fever (1858); Headache (1880); Pneumonia (2011); Blurred Vision (2137); Dizziness (2194); Cough (4457); Eye Pain (4467); Unspecified Eye / Vision Problem (4471)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The fse found that the unit had been serviced by a third-party biomed, who was not trained to service the sterrad® 100nx sterilizer, and the biomed had installed non-asp parts.The catalytic converter, oil mist filter and cartridge, and vacuum pump oil were replaced by the asp fse to resolve the smoke/oil mist issue.However, the unit was not returned to specifications as the customer had additional non-asp parts installed.The customer was advised that only asp parts should be used and was informed that the unit did not meet specifications due to the non-asp part usage.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 Description

A customer reported an event of a ¿smoke¿ or oil mist emitting from the sterrad® 100nx sterilizer that had been occurring for several weeks as they had continued to use the unit.The customer was instructed to power the unit off and discontinue use.An asp field service engineer (fse) was dispatched to assess the unit onsite.Six healthcare workers (hcws) reported reactions of eye, nose, and throat irritation, burning mouth and lips, headache, earache, and fatigue related to the smoke/oil mist.Five of the hcw¿s reactions were resolved without medical treatment.One healthcare worker (hcw) experienced trouble breathing, coughing, chest tightness, sore throat, and fever of 104 degrees.The hcw was seen in urgent care and received a breathing treatment, a steroid shot, and an antibiotic shot.Additionally, a ct scan, x-rays, and blood tests were done, and the hcw reported that the physician diagnosed pneumonia.Medications were prescribed as follows: ipratropium albuterol (breathing treatment), and oral medications: promethazine dm, levofloxacin, medrol.The hcw continued medical treatment while at home with oral steroids for 6 days, oral antibiotics for 10 days, and breathing treatments as needed.She has since returned to work and stated on 7/16/2021 that she is ¿well.¿ this complaint is deemed reportable as a serious injury.The hcw was diagnosed with a respiratory infection and was treated with medications for respiratory and neurological symptoms.Furthermore, this event is being reported as a malfunction subsequent to a previous serious injury for smoke/oil mist.

Manufacturer Narrative

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.The catalytic converter was returned and upon visual inspection differences were identified when compared to the qa part and drawing specification.The part was determined to be non-asp and no further testing was performed.In addition, the oil mist filter was returned and determined to be non-asp as significant differences were found compared to the qa part and drawing specification.No further testing was performed.Asp complaint ref #: (b)(4).

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/oil mist issue, system risk analysis (sra), and visual analysis.¿trending analysis of the smoke/oil mist 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 assignable cause of the smoke/oil mist is likely due to the catalytic converter, oil mist filter and cartridge, and vacuum pump oil which were determined to be non-asp.The asp field service engineer replaced the parts with asp parts and confirmed that this issue was resolved.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 1-DR STERILIZER W/ DUO
• 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 12277631
• MDR Text Key: 265166518
• Report Number: 2084725-2021-00254
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037047581
• UDI-Public: 10705037047581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

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?: No
• Device Operator: 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
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 12/20/2021
• Supplement Dates FDA Received: 10/21/2021; 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female