FDA Adverse Event
Malfunction
Summary report: N
CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
MDR report key: 11653273
·
Received April 12, 2021
Report
- Report Number
- 3012307300-2021-03074
- Event Type
- Malfunction
- Date Received
- April 12, 2021
- Date of Event
- March 15, 2021
- Report Date
- April 12, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD-LEGACY DUODOPA AMBULATORY INFUSION DAY PUMP HAD BEEN ACCIDENTALLY USED IN THE NIGHT AND THE PATIENT RECEIVED 4.4 ML/H INSTEAD OF 2.8 ML/H. PER REPORTER THE PATIENT SLEPT WELL, HAD ENERGY AND HAD A BETTER START UP. IT WAS REPORTED THAT SUBSEQUENTLY THE CONTINUOUS DOSE ON THE NIGHT PUMP WAS REQUESTED TO BE INCREASED IN STEPS OF 0.2ML/H PER WEEK FROM 2.8 TO 3.4 ML/H. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550564 | CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP | PUMP, INFUSION, ENTERAL | LZH | SMITHS MEDICAL ASD, INC. | 1400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |