MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for PYXIS manufactured by Carefusion 303, Inc..
[23540854]
Patient Sequence No: 1, Text Type: N, H10
[23540855]
The pyxis machines have internal light bulbs that are about 6 feet long. They are in a vertical, top to bottom position. There is a long sheet of plastic that serves as a protective barrier that prevents supplies from entering the area where the light bulb is housed. The plastic barrier was broken leaving the light bulb exposed. The area of the pyxis containing the bin of liter bags of normal saline (door 8) had a broken protective barrier and the light bulb was exposed. One of the bags of saline slid into the open area onto the hot, unprotected bulb. Our unit associates who worked that day said that the outer bag burned all of the way through and the actual bag of saline had a brown spot on it but did not burn through. We turned all of the lights inside all of our pyxis units off since the rooms are well lit and you don't really need the internal pyxis lights to see the supplies. This represents a serious fire hazard, and potential safety issue for hospitals that cannot turn off the lights reducing visibility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5017655 |
| MDR Report Key | 5017655 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-07 |
| Report Date | 2015-07-06 |
| Date Reported to FDA | 2015-07-06 |
| Date Reported to Mfgr | 2015-07-06 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYXIS |
| Generic Name | PYXIS CABINET |
| Product Code | BRY |
| Date Received | 2015-08-20 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 303, INC. |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |