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U.S. Department of Health and Human Services

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

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ADVANCED STERILIZATION PRODUCTS STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) Back to Search Results
Catalog Number 10101
Device Problems Chemical Problem; Human-Device Interface Problem
Event Date 05/03/2010
Event Type  Malfunction  
Event Description

The customer reported that a healthcare worker (hcw) experienced h2o2 contact while retrieving a processed package from the sterrad 100s sterilizer after a completed cycle. The hcw stated that there was no visible moisture on the load but she felt moisture after touching the package. The hcw reported white stains and a tingling feeling on the joints of her three middle fingers on her left hand. She rinsed her hands for five minutes and applied alcare ointment. She was informed by an asp associate to keep rinsing her hands until the tingling stopped. The symptoms resolved in thirty minutes and no medical attention was sought. The healthcare worker was not wearing ppe. The vaporizer plate was not in place at the time of the event; however, the customer replaced it with a new one.

 
Manufacturer Narrative

Concomitant devices: 2 cameras - part and serial # unknown, 1retractor - part and serial # unknown, 1bion - part and serial # unknown. 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. Per the ifu, all items must be cleaned and thoroughly dried before loading into the sterilizer. Loads containing moisture may cause cycle cancellation.

 
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 sterrad100s system (serial number (b)(4)) confirmed that the product met all specifications at the time of release. The service and complaint history for the sterrad100s did not reveal a trend for h2o2 skin contact. Trending analysis for h2o2 skin contact issues associated to the sterrad100s did not indicate a significant trend. The hhe (health hazard analysis) relating to exposure to h2o2 contact while handling a processed biological indicator is considered low 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". There was no service performed on the sterrad100s; therefore, there were no parts replaced and no samples returned for investigation. The user did not check the sterilizer to ensure the vaporizer plate was in place. The sterrad100s user's manual states: note: verify that the vaporizer plate is in place prior to starting a cycle. Additionally it warns the customer that without a vaporizer plate in place there is a possibility that h2o2 may remain on the load. The manual also states, "the vaporizer plate minimizes the risk of liquid hydrogen peroxide coming into contact with the load in the chamber. It also helps keep the load and the chamber clean. Operation of the sterilizer without the vaporizer plate in place may result in hydrogen peroxide remaining on the load after a successfully completed cycle. Residual hydrogen peroxide remaining on the load can result in operator contact and/or injury. ".

 
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Brand NameSTERRAD 100S 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 Key1698233
Report Number2084725-2010-00185
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number10101
Is The Reporter A Health Professional? No
Date Manufacturer Received09/24/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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