MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-07-29 for STERRAD 200 STERILIZER 10201-002 manufactured by Advanced Sterilization Products.
[4687727]
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.
Patient Sequence No: 1, Text Type: D, B5
[12232608]
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.
Patient Sequence No: 1, Text Type: N, H10
[25016025]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2014-00142 |
| MDR Report Key | 3963746 |
| Report Source | 05,07 |
| Date Received | 2014-07-29 |
| Date of Report | 2014-04-04 |
| Date of Event | 2014-04-04 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2014-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS GINNY STAMBERGER, MGR |
| Manufacturer Street | 33 TECHNOLOGY DR. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DR. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1026-1027-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD 200 STERILIZER |
| Generic Name | STERRAD EQUIPMENT (MLR) |
| Product Code | FLF |
| Date Received | 2014-07-29 |
| Model Number | NA |
| Catalog Number | 10201-002 |
| ID Number | PART#: 10201002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-29 |