FDA Adverse Event
Death
Summary report: N
ALARIS
MDR report key: 18140201
·
Received November 15, 2023
Report
- Report Number
- 18140201
- Event Type
- Death
- Date Received
- November 15, 2023
- Date of Event
- October 16, 2023
- Report Date
- November 7, 2023
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
TPN (TOTAL PARENTERAL NUTRITION) INFUSION TO RUN VIA PUMP. PUMP PROGRAMMED CORRECTLY. NEONATE GOT BOLUS OF 38.4ML INSTEAD OF 0.8ML/HOUR AS PROGRAMMED. PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907093 | ALARIS | PUMP, INFUSION | FRN | CAREFUSION 303, INC. | 8015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Female | Death |