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 07/19/2016

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction while handling a sterrad® 100nx cassette troubleshooting the sterrad® 100nx sterilizer.The symptoms included a burning sensation from wrist to elbow that lasted a "couple" of minutes.The hcw was wearing personal protective equipment at the time of the event and did not seek or receive any medical attention/treatment and is reported to be "normal." this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Follow up with the customer clarified that the healthcare worker (hcw) experienced a burning sensation from his wrist to elbow after having opened the door to the unit and stated that contact with h2o2 did not occur from handling the cassette.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), concomitant product evaluation, and review of instruction for use (ifu).Method: actual device not evaluated.Result: no results available since no evaluation performed.Dhr could not be performed without lot number provided.Trending of the lot could not be performed without lot number provided.The sra indicates the risk associated with hazard of 'exposure to toxic or corrosive material 'is "low." the product was not returned for evaluation.A field service engineer (fse) was dispatched to the site and resolved h2o2 delivery failure/area too low and noise by adjusting the cassette carriage and by inserting a new cassette.The unit successfully completed a test plan after the repairs were performed.The user stated that contact with h2o2 did not occur during handling of the cassette.As a precaution, the instructions for use of the cassette were reviewed and found to be adequate to address the event of h2o2 contact while handling a cassette, "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to a liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." in this case, contact with hydrogen peroxide did not result in permanent impairment or intervention required.The user believes the burning sensation occurred during troubleshooting of the unit, however, it remains uncertain how h2o2 contact occurred.The issue will continue to be tracked.Without lot number provided and additional information, further investigation could not be performed.A definitive assignable cause could not be determined.

• 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: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5855370
• MDR Text Key: 51456587
• Report Number: 2084725-2016-00454
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

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: 07/19/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• 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