MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2014-09-18 for 3M STERI-VAC STERILIZATION/AERATOR XL 5XL 5XLP manufactured by 3m Health Care.
[4929899]
A manager of the hospital sterile processing department was working with a service technician on 3m steri-vac sterilization/aerator 5xl on (b)(6) 2014. The technician opened the door of the sterilizer. Ethylene oxide allegedly escaped into the room. The technician promptly closed the door. Both the technician and the customer left the room. The customer alleged that he felt light-headed, dizzy, and felt his heart racing. He went outside and then to the hospital occupational health clinic who performed a chest x-ray, ekg and took his blood pressure. On (b)(6) he awoke feeling dizzy and light-headed. He improved enough to drive but then alleged that he felt a lack of air, was sweating, and had a pounding heart. He drove himself to the emergency room where they performed a chest x-ray, ekg and took his blood pressure. He was given an unidentified iv and discharged. He went home with a headache and dizziness for the rest of the evening and took ibuprofen. By (b)(6) he returned to work but he alleged that he did not feel 100% recovered. At the beginning of (b)(6) 2014 the 3m steri-vac unit started making a loud noise. User facility called the 3m service technician. 3m service technician came to the hospital the next day after call to clean the unit. On (b)(6) the sterile processing staff ran one item through the steri-vac and called 3m service technician due to an e78 code displaying on the steri-vac. User facility personnel shut the steri-vac off. On (b)(6) 2014 the steri-vac was serviced. The door was open for about 10 seconds to adjust the inner scan (unclear-rf). Signals skyrocketed and the alarm went off. (b)(6) within the user facility called the operating room to inform them of the ethylene oxide leak.
Patient Sequence No: 1, Text Type: D, B5
[12339589]
Without the s/n it is not possible to determine the manufacturing date of the device. This information was not included in initial report. Issue associated with a device prompting user with an error message in order to indicate a device problem. The interaction between the device and the user caused or contributed to the error. This includes inappropriate use of the device or failure to appropriately maintain the device. Note: device was undergoing servicing and did not need to be returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2014-00067 |
| MDR Report Key | 4136223 |
| Report Source | 00,06,07 |
| Date Received | 2014-09-18 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-08-22 |
| Date Mfgr Received | 2014-08-27 |
| Date Added to Maude | 2014-10-03 |
| 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 | LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-6E |
| 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 STERI-VAC STERILIZATION/AERATOR XL |
| Generic Name | ETHYLENE OXIDE GAS STERILIZER |
| Product Code | FLF |
| Date Received | 2014-09-18 |
| Model Number | 5XL |
| Catalog Number | 5XLP |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| 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 | 2014-09-18 |