FDA Adverse Event
Malfunction
Summary report: N
AQUADEX FLEXFLOW SYSTEM
MDR report key: 8009693
·
Received October 26, 2018
Report
- Report Number
- 3007137787-2018-00007
- Event Type
- Malfunction
- Date Received
- October 26, 2018
- Date of Event
- September 22, 2017
- Report Date
- October 26, 2018
- Manufacturer
- CHF SOLUTIONS, INC.
- Product Code
- KDI
- UDI-DI
- 37332414112388
- 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 "DISCAREDED" 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 WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED SHORTLY AFTER TREATMENT BEGAN WITH THE CIRCUIT. 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 |
|---|---|---|---|---|---|---|---|
| 849734 | AQUADEX FLEXFLOW SYSTEM | ULTRAFILTRATION SYSTEM | KDI | CHF SOLUTIONS, INC. | 7826 | 37332414112388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |