MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-02-29 for 3M[TM] STERI-VAC[TM] GAS STERILIZER/AERATOR 4XL manufactured by 3m Health Care.
[39257585]
Information was not provided. The report indicated female in their (b)(6). Specific information on the serial number was not provided within the system report. Without this information it is no possible to provide a manufacturer date. In follow-up with the service department there was a strong indication the sterilizer was functioning and met specification. It appears the canister may not have been installed correctly into the sterilizer by the user therefore, resulting in its difficulty in removal and the remaining residual eo liquid. End of report
Patient Sequence No: 1, Text Type: N, H10
[39257586]
A female employee in her (b)(6) was operating a 3m steri-vac(tm) gas sterilizer (model 4xl) on (b)(6) 2016. Error codes displayed on the sterilizer screen; the sterilizer was in aeration mode. The woman opened the door of the sterilizer. The ethylene oxide alarm sounded in the room. The woman allegedly removed the canister of ethylene oxide from the sterilizer and tossed it on the floor. The woman alleged that liquid splashed on her right arm. She showered immediately and was taken by ambulance to the facility's occupational medical clinic. She showered again for 15 minutes and was evaluated by a physician. An area of redness was noted on the woman's right arm. The area was treated with hydrocortisone cream. The next day the woman alleged the red area burned; the redness was allegedly visible two days later. The woman asked to be seen again by the physician but the physician did not believe it was necessary based on the earlier evaluation. No information was provided about a follow-up visit. It is presumed that the canister may not have been set correctly into the chamber of the sterilizer. The sterilizer did not malfunction.
Patient Sequence No: 1, Text Type: D, B5
[41360237]
It should be noted that the device was not evaluated as indicated in the initial report. The machine involved in the event is old. There has not been a request for a scheduled maintenance for 2-3 years. The unit used did display an e76 error code (which indicates an interlock relay failure) and an e50 error code (which indicates that the canister wasn't punctured or was empty). The machine was in aeration at the time of the event.
Patient Sequence No: 1, Text Type: N, H10
[41360238]
Additional information was received on (b)(6) 2016 that was not provided in the initial report. Medical report from the employee's visit to the occupational medical clinic alleged chemical exposure to the skin on the arms and face. The severity of illness was noted to be mild. There was no mention of a burn. The employee reported on (b)(6) that her lips felt dry with a possible burning sensation. The alleged skin exposure on the arms and face resolved without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00026 |
| MDR Report Key | 5466854 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-29 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-02-05 |
| Date Mfgr Received | 2016-03-08 |
| Date Added to Maude | 2016-02-29 |
| 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. LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY |
| Manufacturer Street | 1617 NORTH FRONT ST. |
| Manufacturer City | NEW ULM MN 56073 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56073 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M[TM] STERI-VAC[TM] GAS STERILIZER/AERATOR |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2016-02-29 |
| Model Number | 4XL |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-29 |