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

Catalog Number 10202-002

Device Problem Device Emits Odor (1425)

Patient Problems Bronchospasm (2598); No Code Available (3191)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

A customer reported an event of an "oil smell¿ emitting from the sterrad 200 sterilizer.One healthcare worker (hcw) had reactions of a tight, burning sensation in the back of his throat and a mild bronchospasm.The hcw reported a history of asthma and ¿a sensitive airway.¿ the hcw used his personal inhaler to resolve the mild bronchospasm and did not seek or receive any medical attention/treatment.The hcw is reported to be "healthy and well." 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.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.The vacuum pump oil, catalytic decomp filter, and oil mist filter were 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 (10/05/2013 to 04/03/2014) did not reveal a significant trend for this same issue.The trend of the product malfunction code odor/smells was completed from september 2012 through august 2013 and revealed a significant trend which was addressed through capa.The trending for problem code respiratory reaction (may 2013 through april 2014) did not reveal a significant trend.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.The catalytic converter was visually inspected and was found to have a broken top part.The reason for return of the catalytic converter was confirmed.The oil mist filter was returned and tested.The oil mist filter produced a significant amount of odor during pump down.The reason for return of the oil mist filter was confirmed.The vacuum pump oil was not returned.Asp will continue to track and trend this issue.

• Brand Name: STERRAD 200 STERILIZATION SYSTEM
• Type of Device: STERRAD EQUIPMENT (MLR)
• 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: ginny stamberger ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 3776708
• MDR Text Key: 4445427
• Report Number: 2084725-2014-00157
• Device Sequence Number: 1
• Product Code: MLR
• 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: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10202-002
• Other Device ID Number: 10202002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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