FDA Adverse Event
Malfunction
Summary report: N
CADD-LEGACY PUMP
MDR report key: 7712342
·
Received July 23, 2018
Report
- Report Number
- 3012307300-2018-02851
- Event Type
- Malfunction
- Date Received
- July 23, 2018
- Date of Event
- June 7, 2018
- Report Date
- July 23, 2018
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586019548
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE CADD LEGACY PUMP HAS TWO BEEPS AND NO ERROR MESSAGE. DIAGNOSIS OR REASON FOR USE: PAH. DOSE OR AMOUNT: 30 NKM, FREQUENCY: CONTINUOUS, ROUTE: SUB Q. NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553925 | CADD-LEGACY PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 6400 | 10610586019548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |