FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION, SET, PRODUCT CODE: FPA
MDR report key: 9630694
·
Received January 27, 2020
Report
- Report Number
- 3012307300-2020-00713
- Event Type
- Malfunction
- Date Received
- January 27, 2020
- Report Date
- January 26, 2020
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- UDI-DI
- 10610586027468
- PMA / PMN Number
- K031361
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD HIGH-VOLUME ADMINISTRATION SET MAY HAVE UNDER DELIVERED MEDICATION. PER REPORTER THE PUMP READS 30 MLS AFTER INFUSION, WITH AN OVER FILL OF 50 MLS. IT WAS REPORTED THAT VARIOUS AMOUNTS WERE LEFT IN THE BAG AFTER INFUSION RANGING FROM 100 MLS TO 600 MLS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95482 | ADMINISTRATION, SET, PRODUCT CODE: FPA | SET, ADMINISTRATION, INTRAVASCULAR ; PRODUCT CODE: FPA | FPA | SMITHS MEDICAL ASD, INC. | 21-7381-24 | 3823339 | 10610586027468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |