FDA Adverse Event
Injury
Summary report: N
AQUADEX SMARTFLOW
MDR report key: 22133883
·
Received June 3, 2025
Report
- Report Number
- 3007137787-2024-00002
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- November 11, 2024
- Report Date
- December 12, 2024
- Manufacturer
- NUWELLIS, INC
- Product Code
- KDI
- UDI-DI
- 10853072007029
- PMA / PMN Number
- K192756
- Removal / Correction Number
- TO BE ASSIGNED
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THIS IS A FOLLOW-ON TO OUR MANUFACTURER REPORT # 3007137787-2024-00001, WITH THE SAME PATIENT ("PATIENT 1"). CUSTOMER REPORTS THAT WHILE ON AQUADEX SMARTFLOW THERAPY, WEIGHT MISMATCH ALARM OCCURED ON (B)(6) 2024; APPROXIMATELY 100 ML EXCESS WAS PULLED IN 45 MINUTES. CUSTOMER REPORTS "AGITATION RESTLESSNESS" AND THAT 2 BOLUSES OF FLUID WERE ORDERED (10 ML/KG EACH). ULTRAFILTRATION RATE WAS DROPPED TO ZERO IN RESPONSE TO WEIGHT MISMATCH ALARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 875540 | AQUADEX SMARTFLOW | AQUADEX | KDI | NUWELLIS, INC | A06163 | 22698 | 10853072007029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Unknown | Required Intervention |