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U.S. Department of Health and Human Services

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

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STERIS MEXICO, S. DE R.L. DE C.V. 36" CENTURY STERILIZER Back to Search Results
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.
 
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Brand Name36" CENTURY STERILIZER
Type of DeviceSTERILIZER
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 Key9349775
MDR Text Key199552398
Report Number3005899764-2019-00089
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
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

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