MAUDE Adverse Event Report: STERIS CORPORATION ETHYLENE OXIDE STERILANT; ETHYLENE-OXIDE GAS TO 3017 ETO STERILIZER

Lot Number 280616

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

The failed to hold vacuum alarm was attributed to an eo cartridge leak.The sterilizer operated properly when the eo cartridge leak was detected.An exhaust and air wash sequence in the sterilizer occurred and the chamber door remained locked.When this sequence occurs only a qualified serviceman can unlock the chamber door.A steris service technician arrived onsite to inspect the sterilizer.During the technician's inspection, he confirmed the 3017 eto sterilizer had alarmed due to an eo cartridge leak.The technician tested the sterilizer and found it to be operating properly.No issues were noted with the sterilizer and the unit was returned to service.The operator manual states (pp.6-6), "the chamber door(s) remains locked until completion of the programmed exhaust or aeration phase or during power failure." the operator manual states (pp.2-2), "the door lock remains locked throughout the entire cycle, even if power is removed, no matter what the chamber pressure is.The chamber door cannot be opened if the lock is engaged." the operator manual states (pp.2-3), "the chamber temperature and vacuum are continually monitored throughout the cycle, and in the event of any abnormality, the normal exhaust and air wash sequence is performed before the door is unlocked." the 3017 sterilizer remains in service and no additional issues have been reported.Investigation of this event is currently in process to determine the cause of the eo cartridge leak.A follow-up report will be submitted when the investigation is completed.

Event Description

The user facility reported their 3017 eto sterilizer alarmed due to a failure to hold vacuum.No injury, procedure delays or cancellations were reported.

Manufacturer Narrative

During steris' investigation of the reported event, it was determined that the eo cartridge leak was contained within the sterilizer and no eo leaked outside of the unit.The sterilizer operated properly when the eo cartridge leak was detected.An exhaust and air wash sequence in the sterilizer occurred and the chamber door remained locked.When this sequence occurs only a qualified serviceman can unlock the chamber door.The steris technician tested the unit and confirmed it to be operating properly.The unit was returned to service and no additional issues have been reported.

• Brand Name: ETHYLENE OXIDE STERILANT
• Type of Device: ETHYLENE-OXIDE GAS TO 3017 ETO STERILIZER
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6332473
• MDR Text Key: 67860161
• Report Number: 1937531-2017-00003
• Device Sequence Number: 1
• Product Code: FLF
• 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
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 280616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other