MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-07 for 3017 ETO STERILIZER M1301043 manufactured by Steris Mexico, S. De R.l. De C.v..
[21413576]
The user facility reported that an ethylene oxide alarm went off when an employee opened the sterilizer door, allowing ethylene oxide gas to be released from the sterilizer. The sterilizer was in the process of being serviced by a steris service technician and had been placed into service mode and tagged as 'do not use' at the time of this event. Three facility employees were in the area of the sterilizer when the door was opened. Two employees reported to the facility emergency room for headaches, itching, irritated throat, and one employee experienced high blood pressure. A third employee reported to the facility employee health department for a headache. Two of the employees did not receive any medical treatment as a result of their reported symptoms. One of the employees followed up with her family physician after the reported event and was given tylenol. The facility reported all three employees are fully recovered with no sustaining injuries.
Patient Sequence No: 1, Text Type: D, B5
[21431811]
A steris service technician was initially onsite to service another sterilizer when he was notified by a hospital employee that the sterilizer involved in this event was not operating properly. Upon inspection, the technician noted that an air pressure valve was set too high and the unit was out of printer paper. The technician put the sterilizer into service mode and tagged it as "do not use" and left the sterilizer room momentarily. When the technician left the sterilizer room, user facility employees opened the door with a non-aerated load inside. When the technician returned, he allowed the unit to aerate overnight, adjusted the unit's air pressure valve, replaced the unit's printer paper, adjusted the unit's retract and extend switches, tested the unit returning it to service. No further issues have been reported with the equipment. Steris has determined the cause of this event to be user error as the technician tagged the unit as "do not use" and put it into service mode prior to conducting service on the unit. The technician also verbally notified facility biomedical personnel and two of the facility employees that were later injured not to use the sterilizer. Page 6-12 further warns users "do not open the sterilizer door before full aeration is completed without following the 'pausing aeration' procedure. " steris scheduled refresher in-service training regarding the proper use and operation of the sterilizer for (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2010-00014 |
| MDR Report Key | 1747792 |
| Report Source | 06 |
| Date Received | 2010-07-07 |
| Date of Report | 2010-07-02 |
| Date of Event | 2010-06-02 |
| Date Mfgr Received | 2010-06-02 |
| Date Added to Maude | 2012-03-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3017 ETO STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2010-07-07 |
| Model Number | M1301043 |
| 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 MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, NUEVO LEON 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-07 |