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U.S. Department of Health and Human Services

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

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ADVANCED STERILIZATION PRODUCTS STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) Back to Search Results
Catalog Number 10033
Device Problems Chemical Problem; Human-Device Interface Problem
Event Date 04/19/2010
Event Type  Malfunction  
Event Description

The customer reported that an experienced healthcare worker (hcw) experienced a skin reaction while removing instruments from a tray of a completed sterrad nx cycle. The hcw noticed liquid on and under a scope. The hcw reported h2o2 contact on her hands. The area was rinsed and flushed for 15 minutes. Medical attention was not received. The hcw was not wearing ppe. It is reported that the hcw is fine. An asp field service engineer assessed the unit onsite.

 
Manufacturer Narrative

An asp field service engineer (fse) performed service on the sterrad nx. The fse found the unit functioning properly. The unit was tested, an empty cycle was run. The fse stated that the unit meets specifications. The fse discussed with the customer the need for high pressure air to clear water from load items. Customer stated they will address this issue asap (as soon as possible). The ifu states the following: warning! hydrogen peroxide is corrosive concentrated hydrogen peroxide is corrosive to skin, eyes, nose, throat, lungs, and the gastrointestinal tract. Always wear chemical resistant latex, pvc (vinyl), or nitrile gloves when removing items from the sterilizer following a cancelled cycle or if any moisture is noted on items in the load following a completed cycle.

 
Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history, the service and complaint history, trending by product line and system serial number, the health hazard analysis and the system hazard and user misuse analysis. The dhr (device history review) for sterrad nx system (serial number (b)(4)) confirmed that the product met all specifications at the time of release. The service and complaint history for the sterrad nx did not reveal a trend for h2o2 skin contact. Trending analysis for h2o2 skin contact issues associated to the sterrad nx is considered a low, not significant trend. The hhe (health hazard analysis) relating to exposure to h2o2 contact is considered none/ negligible risk. The severity of an injury is considered limited (transient, self-limiting illness or minor injury). The shuma (system hazard and user misuse analysis) is reported to be a category (b)(4) or "broadly acceptable risk". The system was serviced following the event and was found to meet all system specifications. There were no parts replaced on the sterrad nx; therefore, there were no samples returned for investigation. The root cause was user error, failure to follow the ifu. The healthcare worker noted moisture in the tray, and did not wear personal protective equipment when removing the load from the completed cycle.

 
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Brand NameSTERRAD NX STERILIZER
Type of DeviceSTERRAD EQUIPMENT (MLR)
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
irvine CA 92618
Manufacturer Contact
ginny stamberger
33 technology drive
irvine , CA 92618
9497893837
MDR Report Key1686267
Report Number2084725-2010-00171
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number10033
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/21/2010
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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