MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 200 STERILIZER; STERRAD EQUIPMENT (MLR)

Catalog Number 10201-002

Device Problem Device Emits Odor (1425)

Patient Problem Headache (1880)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

A customer reported an event of a "strong odor" emitting from the sterrad 200 sterilizer.One healthcare worker (hcw) experienced a reaction of headache.The hcw did not seek or receive any medical attention/treatment and reported the "headache is gone." an asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

A field service engineer was dispatched to customer site.Odor/smell was confirmed.A preventative maintenance (pm1) was performed and the catalytic decomp filter was replaced.Unit meets specifications and was returned to service on (b)(4) 2014.

Manufacturer Narrative

Conclusion: root cause identified in capa was found to be premature failure/saturated oil mist filter or vacuum pump oil.Asp investigation summary: the investigation included a review of the device history record, service history, trending of the product malfunction code, failure mode and effects analysis, health hazard evaluation, system hazard and user misuse analysis, and capa.The dhr (device history record) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.The service history for this unit for the past 6 months (10/06/2013 to 04/04/2014) did not reveal a significant trend for this same issue.The trend of the product malfunction code odor/smells was completed from may 2013 through april 2014 and revealed a significant trend which was addressed through capa.The trending for problem code human reaction (may 2013 through april 2014) revealed the highest risk is considered broadly acceptable.The fmea (failure mode and effects analysis) revealed the risk priority number for this failure mode is (b)(4) which is greater than the acceptable limit.A capa was opened to address this issue.The hhe (health hazard evaluation) was reviewed for the risk of odor and smell exposure.The severity and occurrence for the general population were limited (transient, minor impairment, no medical treatment required) and the product problem has been known to result in the identified harm, but only occasionally and/or under unusual circumstances.The shuma (system hazard and user misuse analysis) determined the risk is as low as reasonably practicable for exposure to odor or odorants.The capa (corrective and preventative action) identified the root cause for the odor/smells issue as: premature failure of the used and saturated sterrad® 200 oil mist filter caused oil vapor emissions that exacerbated the odor/smell complaints reported for the sterrad® 200 system.The use of a less oxidatively stable vacuum pump oil caused the odor/smells for the sterrad® 200 system.No parts were returned for further evaluation.Asp will continue to track and trend this issue.

• Brand Name: STERRAD 200 STERILIZER
• Type of Device: STERRAD EQUIPMENT (MLR)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology dr.; irvine CA 92618
• Manufacturer Contact: ginny stamberger, mgr ; 33 technology dr.; irvine, CA 92618 ; 9497893837
• MDR Report Key: 3963746
• MDR Text Key: 4687727
• Report Number: 2084725-2014-00142
• Device Sequence Number: 1
• Product Code: FLF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10201-002
• Other Device ID Number: PART#: 10201002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2004
• 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-1026-1027-2013
• Patient Sequence Number: 1