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

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 02/19/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their century sterilizer was emitting steam from the bottom of the unit.No report of injury or procedural delay or cancellation.The fire alarm was activated due to the event, however, no facility evacuations were required.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the sterilizer, and identified the unit's steam strainer and jacket strainer were obstructed with debris, specifically lime, originating from the facility's incoming steam line.The obstruction of these two components did not allow for the facility's incoming steam to enter the processing chamber, and thus resulted in the steam leak from the bottom of the unit.The technician cleaned the associated facility piping, performed the required repairs to the century sterilizer, tested and confirmed the unit was operating according to specification and returned the unit to service.The century sterilizer operator manual, table 11-1, provides maintenance activities along with recommended frequency intervals to ensure the proper operation of the century sterilizer.Table 11-1 instructs the user to inspect the steam and jacket strainer for debris, and clean as needed at a minimum frequency of two times per year.The technician has confirmed that the user facility is aware of the issues with their piping and believes the poor quality of their pipes resulted in the reported event.No further issues have been reported.

• 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 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4614475
• MDR Text Key: 5696968
• Report Number: 3005899764-2015-00019
• 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: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• 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: 02/19/2015
• 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