FDA Adverse Event
Malfunction
Summary report: N
CADD
MDR report key: 10257795
·
Received July 10, 2020
Report
- Report Number
- 3012307300-2020-07158
- Event Type
- Malfunction
- Date Received
- July 10, 2020
- Report Date
- August 25, 2020
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586019548
- PMA / PMN Number
- K982838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ORACLE RO 1073540: ALARMS "AIR IN LINE". ADDITIONAL INFORMATION RECEIVED ON 30-JUN-2020: NO FURTHER INFORMATION AVAILABLE. INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD LEGACY 1 PUMPS - 6400 . SUMMARY IN H 10.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED "AIR IN LINE" ALARMS. NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725088 | CADD | LEGACY | FRN | ST PAUL | 6400 | 10610586019548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |