MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" CENTURY STERILIZER

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found a leak from one of the brass fittings subsequently causing the reported event to occur.The unit was installed in (b)(6) 2007 making the unit approximately 11 years old.The technician replaced the fitting, ran a test cycle, confirmed the unit to be operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that an employee slipped and fell on water leaking from their 60" century sterilizer.No medical treatment was sought or administered.

• Brand Name: 60" 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: 8337158
• MDR Text Key: 137032510
• Report Number: 3005899764-2019-00012
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• 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: 01/16/2019
• 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