MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® NX STERILIZER; STERRAD EQUIPMENT

Catalog Number 10033

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to customer site.The etx board and scan engine were replaced to resolve the power interrupt issue.Unit meets specifications and was returned to service.(b)(4).

Event Description

A customer reported their sterrad® nx sterilizer is cancelling cycles intermittently due to power being interrupted.The customer stated they did attempt to reboot the system but the unit continues to shut off during cycles and it was reported the cancelled loads were released without reprocessing.A field service engineer (fse) was dispatched to assess the unit onsite.There is no report of any infections or injuries as a result of this issue.However, this event is being reported since advanced sterilization products (asp) cannot guarantee sterility.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the load not recalled issue and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the load not recalled issue was reviewed from april 2017 to october 2017 and no significant trend was observed.The sra shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." the customer released a load from a cancelled cycle prior to reprocessing.Further information regarding the event and the released load is not available as the customer did not respond to asp¿s follow-up attempts.Should additional information become available, the complaint file will be re-opened and re-evaluated.A letter was sent to the customer in regards to always following the instructions for use (ifu) and reprocessing cancelled cycles prior to use.The issue was resolved at the customer site.Asp will continue to track and trend this issue.

• Brand Name: STERRAD® NX STERILIZER
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 7041852
• MDR Text Key: 93065417
• Report Number: 2084725-2017-00654
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• PMA/PMN Number: K042116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

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: 10033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 12/28/2017
• Supplement Dates FDA Received: 12/28/2017
• Date Device Manufactured: 09/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1