FDA Adverse Event
Malfunction
Summary report: N
AQUADEX FLEXFLOW SYSTEM
MDR report key: 7915531
·
Received September 27, 2018
Report
- Report Number
- 3007137787-2018-00003
- Event Type
- Malfunction
- Date Received
- September 27, 2018
- Date of Event
- September 5, 2018
- Report Date
- September 27, 2018
- Manufacturer
- CHF SOLUTIONS, INC.
- Product Code
- KDI
- UDI-DI
- 07332414112387
- PMA / PMN Number
- K071854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE UF 500 BLOOD CIRCUIT WAS DISCARDED BY THE FACILITY AND WAS NOT RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE BLOOD LEAK COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED. THE BLOOD LEAK OCCURED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED AFTER TWO HOURS OF CIRCUIT USE. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756316 | AQUADEX FLEXFLOW SYSTEM | ULTRAFILTRATION SYSTEM | KDI | CHF SOLUTIONS, INC. | UF 500 | 7966 | 07332414112387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |