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

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 36" century sterilizer and found no issue with the function or operation of the sterilizer.No repairs were required.While onsite, the technician observed current cleaning practices performed by facility personnel and identified that they did not open the chamber emergency manual exhaust valve prior to cleaning the chamber as stated in the operator manual when open, the exhaust valve routes liquid and/or pressure within the chamber directly to the drain.As facility personnel did not open the exhaust valve during cleaning activities, the water would not have drained until the next cycle was started.The exhaust valve should be opened prior to cleaning the chamber to ensure liquids are able to appropriately drain from the chamber.As the valve was not opened by the user facility during the cleaning of the chamber, the water used was not able to drain from the sterilizer resulting in the formation of the water line on the chamber floor over time.The root cause of the reported event is improper cleaning practices by the user facility as facility personnel should have opened the exhaust valve prior to cleaning the chamber to allow any water used during the cleaning process to drain.The medium century sterilizer operator manual states (7-3), "7.1.2 clean chamber, important: chamber must be at room temperature, sterilizer off all night, before washing.Open the chamber emergency manual exhaust valve." the user facility does not have a service agreement with steris; the user facility is responsible for performing all maintenance activities.Prior to receipt of the medwatch report, steris had not been contacted regarding any issues with this sterilizer since august 2012.While onsite, the technician performed in-service training on proper cleaning practices for the century sterilizer, specifically opening the exhaust valve prior to cleaning the chamber.No additional issues have been reported.

Event Description

The user facility reported via user facility medwatch report # (b)(4) that their 36" century sterilizer was not draining after facility personnel's weekly cleaning of the chamber resulting in formation of a water line on the chamber floor over time.No injuries were associated with the reported event.

• 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, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9349775
• MDR Text Key: 199552398
• Report Number: 3005899764-2019-00089
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• 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