MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for PYXIS ANESTHESIA SYSTEM (PAS) 4000 manufactured by Carefusion.
[24592837]
(b)(4). Field service technician serviced device and found evidence of fluid ingression which caused all the controller boards and smart cables in the within the device to short out. All affected parts were replaced and the device tested normal.
Patient Sequence No: 1, Text Type: N, H10
[24592838]
The customer reported an accidental spill of iv fluids into the back components of the pyxis anesthesia system (pas) device. The fluids ingressed and caused an electrical burn odor and smoke. The device was disconnected from power and removed from the room. Alternative measures were taken for medication administration. There was a case in progress at the time of the occurrence; however, there was no harm to the patient or user and there was no delay in medication access.
Patient Sequence No: 1, Text Type: D, B5
[45224295]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016493-2015-00596 |
| MDR Report Key | 5011680 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-23 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2013-04-23 |
| Date Added to Maude | 2015-08-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SYLVIA VENTURA |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214386 |
| Manufacturer Phone | 8586172000 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 921214386 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYXIS ANESTHESIA SYSTEM (PAS) |
| Generic Name | AUTOMATED DISPENSING CABINET (ADC'S) |
| Product Code | BRY |
| Date Received | 2015-08-18 |
| Model Number | 4000 |
| Catalog Number | 4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 921214386 US 921214386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-18 |