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 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to customer site and she/he adjusted the duo pump.Unit meets specifications and was returned to service on 01/17/2017.

Event Description

A customer reported a three health care workers (hcw) experienced skin reactions trying to reinsert the sterrad 100nx cassette into the unit after a cancelled cycle.This reported is for (b)(6) who experienced a burn.Details of the affected area are unknown; however, it was reported the hcw did not receive medical attention.The hcw was not wearing personal protective equipment (ppe).The hcw was advised by the advanced sterilization products (asp) representative to always wear ppe when touching cassettes.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 two of three 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2017-00075, 2084725-2017-00076 and 2084725-2017-00077.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, lot trending, 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 lot number was unavailable.¿ trending analysis by lot was not reviewed as the lot number was not available.¿the sra indicates the risk associated with exposure to 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).The customer was advised to always wear proper ppe while handling cassettes to avoid this issue in the future.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: 6330611
• MDR Text Key: 67439825
• Report Number: 2084725-2017-00076
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

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: 01/23/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• 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