FDA Adverse Event
Other
Summary report: N
PYXIS ANESTHESIA SYSTEM (PAS)
MDR report key: 3767717
·
Received April 15, 2014
Report
- Report Number
- 2016493-2014-00002
- Event Type
- Other
- Date Received
- April 15, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 14, 2014
- Manufacturer
- CAREFUSION
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL DATA/FAILURE INVESTIGATION. INVESTIGATION INDICATED THAT THERE WAS A CUSTOMER CAUSED FLUID INGRESSION INTO THE UPS WHICH RESULTED IN THE BURNED OUT COMPONENTS AND SMOKE THAT WAS OBSERVED. CUSTOMER CONFIRMED THE SPILL OF SALINE INTO THE UNIT.
Description of Event or Problem · 1
CUSTOMER REPORTED OBSERVING SMOKE FROM THE UNINTERPRETABLE POWER SUPPLY (UPS) OF THE DEVICE. PT WAS PRESENT, NO HARM AND NO DELAY IN CARE. NO HARM TO USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230750 | PYXIS ANESTHESIA SYSTEM (PAS) | AUTOMATED DISPENSING CABINET (ADC'S) | BRY | CAREFUSION | 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |