FDA Adverse Event
Malfunction
Summary report: N
CADD LEGACY PLUS PUMP
MDR report key: 10396896
·
Received August 12, 2020
Report
- Report Number
- 3012307300-2020-08101
- Event Type
- Malfunction
- Date Received
- August 12, 2020
- Report Date
- September 15, 2020
- Manufacturer
- ST PAUL
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PREVIOUS FOLLOW UP REPORT SHOULD'VE BEEN SENT AS A CORRECTION REPORT WITH 09-14-2020 AS THE AWARE DATE.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PUMP WAS ALARMING "NO DISPOSABLE, CLAMP TUBING" WHEN A CASSETTE WAS ATTACHED. THERE WAS NO PATIENT INJURY. THERE WERE NO REPORTED ADVERSE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862781 | CADD LEGACY PLUS PUMP | PUMP, INFUSION | FRN | ST PAUL | 6500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |