MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100S STERILIZER; STERRAD EQUIPMENT (MLR)

Catalog Number	10101
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to customer site.The catalytic decomp filter, iso-kf center ring and vacuum pump filter exhaust were replaced to resolve the haze/mist/vapor issue.Unit meets specifications and was returned to service on 02/15/2017.
Event or Problem Description
A customer reported a fluid leak and haze emitting from the sterrad® 100s sterilizer.Two healthcare worker (hcw¿s) experienced a headache and dizziness.The hcw¿s did not seek or receive any medical attention/treatment and are reported to be fine.The customer was advised to turn the unit off and leave the room.An asp field service engineer was dispatched to assess the unit onsite.There are no serious injuries reported with this event; however, this is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device history record (dhr), functional analysis and system risk analysis (sra).The vacuum pump exhaust filter was returned and tested.The reason for the return of the vacuum pump exhaust filter was not confirmed.The catalytic decomp filter was returned and tested.The reason for the return of the catalytic decomp filter was not confirmed.The iso-kf center ring was returned and tested.The reason for the return of the iso-kf center ring was not confirmed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the assignable cause of the haze/mist/vapor issue is the vacuum pump exhaust filter, catalytic decomp filter and iso-kf center ring.The field service engineer replaced these parts and confirmed the sterrad® 100s.The unit was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.

• Brand Name: STERRAD 100S STERILIZER
• Common Device Name: STERRAD EQUIPMENT (MLR)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 6382604
• Report Number: 2084725-2017-00116
• Device Sequence Number: 442123
• Product Code: MLR
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K991999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2017

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
• Other Device ID Number: 10101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 03/07/2017; 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1