MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX CASSETTE; STERRAD 100NX STERILIZER

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem Skin Irritation (2076)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while touching a cassette from a sterrad® 100nx.After insertion, the unit rejected the cassette.Consequently, the hcw experienced burning and blanching on her finger.The hcw was not wearing personal protective equipment (ppe) and symptoms were reported to last for one hour.The hcw flushed her finger with water for 15 minutes.The hcw did not seek any medical attention/treatment.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, and system hazard and user misuse analysis (shuma).Method- service history, trending and shuma reviewed.¿the dhr was not reviewed as the lot number of the cassette was not available.¿specific information regarding the lot number of the suspect product is not available.No lot trending can be performed.¿the trend for the product malfunction code of skin reaction was assessed from november of 2013 through october of 2014.The risk is considered "remote." ¿the shuma indicates the risk is broadly acceptable.The instructions for use (ifu) of the sterrad® 100nx state: "warning! hydrogen peroxide may be present.Wear chemical resistant latex, pvc (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or when disposing of a cassette.Hydrogen peroxide liquid may be present on the cassette, the load or in the chamber." testing was not performed as there was no product returned.The assignable cause is attributed to user error.The customer was educated to use proper ppe when handling used cassettes.Review of tracking and trending data did not reveal a trend.As a result, root cause was not performed.

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• 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: 4072716
• MDR Text Key: 4742515
• Report Number: 2084725-2014-00301
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 09/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR