FDA Adverse Event
Malfunction
Summary report: N
9611369-2008-00496
MDR report key: 1140463
·
Received June 16, 2008
Report
- Report Number
- 9611369-2008-00496
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Product Code
- KDI
- PMA / PMN Number
- K010667
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. AS SOON AS WE HAVE THE SAMPLE ON HAND WE WILL START WITH THE INVESTIGATION. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THE MOMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KDI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |