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 2012-09-14 for 3M STERI-VAC 5XL STERILIZER/AERATOR manufactured by 3m Health Care.
[2891919]
3m received information from a biomedical engineer that reported he was exposed to ethylene oxide (eo) when he was repairing a 3m steri-vac 5xl sterilizer that had stopped functioning and was displaying an e73 error. Reportedly, he was not wearing a monitor and there was no alarm in the room. He stated he tried to perform a "clear silent abort" as instructed on page 45 of the service manual but the sterilizer didn't respond. He then terminated the cycle by turning the power off, set the dip switches to invoke the "reset cycle to idle" process, turned the power back on, manually opened the door (while gas was in the chamber) and pressed the stop button (which has no effect after the reset cycle to idle procedure has been performed). The reported exposure occurred because, although the engineer did check the error code listing on page 45, he did not go to page 76 for the proper and safe address of the e73 error code which says do not cycle the power.
Patient Sequence No: 1, Text Type: D, B5
[10184875]
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 | 2110898-2012-00035 |
| MDR Report Key | 2750059 |
| Report Source | 04,06,07 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-06-06 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-09-20 |
| 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 5XL STERILIZER/AERATOR |
| Generic Name | 880.6860 STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2012-09-14 |
| Model Number | NA |
| Catalog Number | 5XL |
| Lot Number | NA |
| ID Number | UPC# 00707387523749 |
| Operator | OTHER |
| 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 | 2012-09-14 |