MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 20" CENTURY STERILIZER

Device Problem Gas/Air Leak (2946)

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

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

A steris technician arrived onsite following the reported event to inspect the 20" century steam sterilizer.While onsite, the technician found that water in the sterilizer chamber did not properly drain causing residual water to remain in the chamber.When the unit was turned on, the water that was collected in the bottom of the chamber was heated, causing steam to escape through the door seal creating the reported event.The technician confirmed the root cause of this event was attributed to warn valves within the unit's draining system.The valves did not open properly to allow the water to drain, which allowed steam to build up and leak.The technician further inspected the unit's door seal and found it required replacement as steam was able to escape past the seal and into the room where the 20" century steam sterilizer is located.The technician made the appropriate repairs including replacing the door seal, ran a test cycle, and found the unit to be operating according to specification.This unit was installed in december of 2006 and is under steris service agreement.No additional issues have been reported.

Event Description

The user facility reported their 20" century steam sterilizer began leaking steam when the unit was turned on.No injury, procedure delay or cancellations were reported.

• Brand Name: 20" CENTURY STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7720390
• MDR Text Key: 115357435
• Report Number: 3005899764-2018-00069
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1