FDA Adverse Event
Injury
Summary report: N
BD ALARIS 8100 LBP
MDR report key: 11664098
·
Received April 13, 2021
Report
- Report Number
- MW5100772
- Event Type
- Injury
- Date Received
- April 13, 2021
- Date of Event
- April 11, 2021
- Report Date
- April 12, 2021
- Manufacturer
- BD / CAREFUSION 303, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IV PUMP INFUSED 50ML BAG OF LASIX (500MG) IN TWO HOURS, PUMP SCREEN WAS RED AND FLASHING "PUMP FAILURE" ON SCREEN. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555723 | BD ALARIS 8100 LBP | PUMP, INFUSION | FRN | BD / CAREFUSION 303, INC. | ALARIS 8100 LBP | EGF7482, MOD 8374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other| R |