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

Device Problem Gas/Air Leak (2946)

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

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 20" millennium sterilizer.While onsite, the technician was able to identify the root cause of the steam leak to originate from the unit's pressure relief valve (prv).As designed, this valve opened when the unit detected an excess of pressure inside the sterilizer chamber, thus releasing steam.The technician readjusted the high/low pressure switch and prv, ran a test cycle, and found the unit to be operating according to specification.This unit was installed in (b)(6) 2002 and is under steris service agreement.No additional issues have been reported.

Event Description

The user facility reported a steam leak from their 20" millennium sterilizer.No injury, procedure delay, or cancellation was reported.

• Brand Name: 20" MILLENNIUM 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: 7724315
• MDR Text Key: 115368621
• Report Number: 3005899764-2018-00070
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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: 06/26/2018
• 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