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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/04/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician, arrived on-site, inspected the unit, and found that the hot water supply piping and check valves required replacement.The technician identified that the check valves were damaged which allowed hot water or steam to back up within the hot water supply piping.This pressure caused the piping to overheat and fail.Steris service engineering reviewed the reported event and confirmed the technician's assessment of the issue.The technician replaced the hot water supply piping, re-built the check valves, and confirmed the unit to be operating according to specification.The sterilizer was placed back into service and no additional issues have been reported.

Event Description

The user facility reported the hot water supply to their 20" century sterilizer was leaking water.No injury, procedure delay, or cancellation was 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6141726
• MDR Text Key: 61610072
• Report Number: 3005899764-2016-00085
• 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: 12/02/2016

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
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 12/02/2016
• 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