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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 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.

 
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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, 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 Key4614475
MDR Text Key5696968
Report Number3005899764-2015-00019
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 03/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2015
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 Received02/19/2015
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

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