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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the eagle sterilizer.Upon his inspection, the technician found that the user facility's water pressure was set too high.The technician informed the facility and the facility made the appropriate repairs.The technician found that the unit was unable to pass a dart test and had multiple steam leaks.The technician made the necessary repairs including replacing the door gasket, steam chamber valve and fc5 flow control, ran a test cycle, and found the unit to be operating according to specification.The sterilizer was returned to service.While onsite, the technician was informed that the employee subject of the event was wearing proper ppe when the event occurred.However, based on the description of the event and severity of the burn it is unlikely the employee was wearing proper ppe.The eagle sterilizer operator manual (pg 4-7) states: "warning: do not service sterilizer steam traps or strainer until the sterilizer has reached room temperature.Piping may contain hot water, so protective clothing and hand protection must be worn".The eagle sterilizer was installed in 2007 and is not under steris service agreement for maintenance activities.The facilities biomed department is responsible for all maintenance activities.A steris account manager will offer in-service training on the proper use and maintenance of the eagle sterilizer.No additional issues have been reported.

Event Description

The user facility reported their employee obtained a burn while performing maintenance on their eagle sterilizer.Medical treatment was sought and administered.

• Brand Name: EAGLE 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: 8658293
• MDR Text Key: 146933023
• Report Number: 3005899764-2019-00056
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• 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