MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for ETHYLENE OXIDE STERILANT manufactured by Steris Corporation.
[67222902]
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 for 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. " 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.
Patient Sequence No: 1, Text Type: N, H10
[67222903]
The user facility reported their 3017 eto sterilizer alarmed for an eo cartridge leak. No injury, procedure delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[75947255]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937531-2017-00002 |
| MDR Report Key | 6312588 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION |
| Manufacturer Street | 7501 PAGE AVENUE |
| Manufacturer City | ST. LOUIS MO 63133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHYLENE OXIDE STERILANT |
| Generic Name | ETHYLENE-OXIDE GAS TO 3017 ETO STERILIZER |
| Product Code | FLF |
| Date Received | 2017-02-08 |
| Lot Number | 280616 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 7501 PAGE AVENUE ST. LOUIS MO 63133 US 63133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-08 |