FDA Adverse Event
Malfunction
Summary report: N
9611369-2008-00323
MDR report key: 1040704
·
Received April 28, 2008
Report
- Report Number
- 9611369-2008-00323
- Event Type
- Malfunction
- Date Received
- April 28, 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. THERE IS NO SAMPLE AVAILBLE FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KDI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |