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

Catalog Number 10144

Device Problems Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 09/14/2014

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to customer site.The fse found an incorrect collection box being used.Unit meets specifications and was returned to service on 09/15/2016.

Event Description

Three health care workers (hcw) reported h2o2 contact while changing a sterrad 100nx cassette collection box.The hcw's were not wearing personal protective equipment (ppe).There were no serious injuries reported in this event.The customer had initially stated there were two hcw's affected but later reported three hcw's were affected.Hcw#3 stated having a skin reaction on her hand and finger.The affected area was washed with soap and water and his symptoms lasted 20 minutes.No medical attention was sought and the hcw continued to work.This event is being reported as a malfunction report subsequent to a serious injury.(b)(4) are related complaints from the same facility.This is three of three 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2016-00597, 2084725-2016-00596 and 2084725-2016-00598.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation and system risk analysis (sra).The batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was not performed as the cause of the reported issue is user error.The sra indicates the risk associated with toxic or corrosive material is "low." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).It was also determined the customer was using the incorrect collection box in the sterrad unit and was advised of the proper collection box.The customer was informed to always wear ppe while handling cassettes to avoid this issue in the future.The issue was resolved at the site.The issue will continue to be tracked and trended.

• 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: 6025049
• MDR Text Key: 57322438
• Report Number: 2084725-2016-00598
• 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: 09/23/2016

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: 09/23/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• 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