MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 36" CENTURY STERILIZER

Device Problem Leak/Splash (1354)

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

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

A maymedic technology technician arrived on site, inspected the unit, and identified the hi low valve had cracked and required replacement.Based on the information provided to date, the hi low valve replacement part was incorrectly installed.A follow-up mdr will be filed once our service organization provides training on the proper installation of this critical part.

Event Description

The user facility reported their 36" century sterilizer was leaking water and steam.No injury, procedure delay, or cancellation was reported.

Manufacturer Narrative

The maymedic technology technician who was responsible for the installation of the sterilizer's hi low valve was re-trained on the proper installation and maintenance practices for the sterilizer, specifically the installation of the hi low valve.No additional issues have been reported with the sterilizer.

• Brand Name: 36" 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: 7140430
• MDR Text Key: 96048626
• Report Number: 3005899764-2017-00074
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 12/21/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 01/25/2018
• 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