MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2012-01-23 for 3M STERI-VAC 8XL STERILIZER/AERATOR manufactured by 3m Health Care.
[19582888]
3m received information from an industrial customer that two male employees were exposed to ethylene oxide (eo) when the check valve in the exhaust port failed. This installation was a two sterilizer (sn (b)(4)) to one abator installation. The exhaust lines of the sterilizers are connected with a pipe junction and the abator electronically controls sterilizer exhaust priority. One sterilizer was occupied and running a cycle while the adjacent sterilizer was unoccupied with the door closed. The failure in the check valve allowed eo that was exhausting from the occupied sterilizer during ethylene oxide pump down stage to vent into the adjacent unoccupied sterilizer. When the technician opened the door to the unoccupied sterilizer to put a load in, ethylene oxide vented out the door and registered on the sensor at 10 ppm. The employees evacuated the room in less than 30 seconds. One of the employees experienced eye irritation, temporarily, but no medical intervention was required. It was also noted that the eo exposure in room reached a peak of 10 ppm, causing the alarm to sound; the (b)(4) excursion limit of 5 ppm over 15 min was not exceeded. It was noted that no modifications were made to the sterilizers (listed above) configured near the check valve that failed. However, the technicians were running a customer validated cycle that was outside of the fda cleared cycles for use in health care facilities.
Patient Sequence No: 1, Text Type: D, B5
[19650219]
No other adverse pt effects were reported. If additional information is received, a follow-up report will be submitted. No evaluation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00002 |
| MDR Report Key | 2437479 |
| Report Source | 04,06,07 |
| Date Received | 2012-01-23 |
| Date of Report | 2011-12-01 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-12-01 |
| Date Added to Maude | 2012-08-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREA GRABANSKI |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331047 |
| Manufacturer G1 | BALCHEM |
| Manufacturer Street | 95 BALCHEM LANE |
| Manufacturer City | GREEN POND SC 29446544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29446 5443 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-VAC 8XL STERILIZER/AERATOR |
| Generic Name | 880.6860 STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2012-01-23 |
| Model Number | NA |
| Catalog Number | 8XL |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-23 |