MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-01-20 for 3M STERI-VAC STERILIZER/AERATOR 5XL 5XLP manufactured by 3m Health Care.
[4089927]
The female sought medical consultation at the occupational health clinic within the hosp. After exposure to eo. It was reported that the employee experienced a headache and vomiting. At this time, it is not known whether any medical intervention was administered because the hosp would not release this information. It was reported that a female employee within the hospital sterilization facility operating a 5xl eo sterilizer (upper unit) opened the door prior to full aeration after being informed by another hosp employee to abort cycle. The operator did not observe the load was already in aeration (but only for 8 minutes) when she pushed the stop, lifted the latch and opened the door completely. The hosp noted that normal aeration time for this type of load was 12 hours. She then noticed that the eo canister had been puncture, at which time she closed the door. The estimated exposure time to the operator was 15 to 30 seconds. It was reported the sterilizer was in accelerated mode when the event occurred. The accelerated mode should not be used for a standard sterilization process because this mode is only applicable when an unit is being serviced. It was also noted that digital eo room monitor alarmed and indicated a concentration of 2. 1 ppm eight feet away from the sterilizer. The room monitor lower alarm limit was set to 1 ppm and the upper alarm limit set to 5 ppm. The actual amount of exposure to the operator is unknown as reported by the hosp. The hosp department reconfigured the power system (replacement of electrical panel) to accommodate another manufacturer's sterilizer in addition to powering two 5xl units and an abator. The reconfiguration resulted in damage to the controller boards in both units and the plc (controller) due to failure by the facility personnel to power down and isolate the 3m equipment. This made the units unavailable for use for an extended period. The hosp requested service on the sterilization units. Service was performed by 3m service personnel on (b)(4) but subsequent to the servicing of the sterilizers, additional changes were made by a hospital certified electrician. The 3m company service personnel became aware of this information during a phone call, at which time he requested that the units not be used until 3m service personnel returned. However, the hosp continued to use one of the sterilizers and internal, board-mounted switches affecting sterilization mode may have been changed on the upper unit by a hosp employee. The units were serviced by 3m service personnel on (b)(4) 2013 and it was noted the upper unit was in accelerated mode and panels from the units had been removed. The units were fixed and restored for proper use. There was another individual who also experienced exposure at the same time and this has been reported under 2110898-2014-00004.
Patient Sequence No: 1, Text Type: D, B5
[11714942]
There were two units that were replaced on each other. One upper and one lower unit. The upper unit was reported to be on accelerated mode and the reason this report covers serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2014-00003 |
| MDR Report Key | 3608964 |
| Report Source | 06,07 |
| Date Received | 2014-01-20 |
| Date of Report | 2013-12-24 |
| Date of Event | 2013-12-24 |
| Date Mfgr Received | 2013-12-24 |
| Device Manufacturer Date | 1994-07-01 |
| Date Added to Maude | 2014-02-06 |
| 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 City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-VAC STERILIZER/AERATOR 5XL |
| Generic Name | ETHYLENE OXIDE GAS STERILIZER |
| Product Code | FLF |
| Date Received | 2014-01-20 |
| Model Number | 5XL |
| Catalog Number | 5XLP |
| Lot Number | NA |
| ID Number | NA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-20 |