MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Device Problem Fluid Leak (1250)

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

Event Date 04/30/2018

Event Type  Malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the amsco 400 sterilizer and observed towels on the floor around the unit. The technician identified that a valve on the water inlet in the back of the unit required replacement. The technician replaced the valve on the water inlet, ran a test cycle, and found the unit to be operating properly. The sterilizer was installed at the customer's location is 2018 and is under steris service agreement. The steris district service manager has counseled his team to ensure all valves are properly placed and secured during installation activities. No additional issues have been noted.

Event Description

The user facility reported that their amsco 400 sterilizer was leaking water onto the floor. No report of injury.

• Brand Name: AMSCO 400 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: 7554866
• MDR Text Key: 109757258
• Report Number: 3005899764-2018-00037
• 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: 05/30/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/30/2018
• 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
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/30/2018
• 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