MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,06,07 report with the FDA on 2014-02-14 for 3M STERI-VAC ETHYLENE STERILIZER/AERATOR 8XL manufactured by 3m Health Care.
[4567306]
During routine operation, it was reported that an 8xl 3m steri-vac ethylene sterilizer displayed an error code (e71) that triggered the unit's audible alarm. Simultaneously with this alarm the user's provided eo monitor sounded indicating the presence of eo within the operators room. The individuals within the room left immediately resulting in no reported injury or eo exposure.
Patient Sequence No: 1, Text Type: D, B5
[12022374]
The report pertains to a malfunction of the device. This type of failure would always result in an audible sound. The defective part involved in this incident is no longer used in manufacturing and was replace din late 2007 with a new part. The new part's brass bushing and seal is securely fastened onto the mating pocket of the cylinder. 3m continues to investigate the failed part and related event to determine if additional actions are warranted. Any additional actions and findings weill be shared with fda under a supplemental report to this initial report. The unit involved in this event was not returned to the company. The defective part was replaced with the new part (implemented in late 2007) performed under a service repair which took place within the hospital facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2014-00013 |
| MDR Report Key | 3881240 |
| Report Source | 01,04,06,07 |
| Date Received | 2014-02-14 |
| Date of Report | 2014-01-16 |
| Date of Event | 2014-01-15 |
| Date Mfgr Received | 2014-01-16 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 2014-07-02 |
| 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, REG. AFFAIRS |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-VAC ETHYLENE STERILIZER/AERATOR |
| Generic Name | STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2014-02-14 |
| Model Number | 8XL |
| Catalog Number | 8XL |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE. ST. PAUL MN 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-14 |