FDA Adverse Event
Malfunction
Summary report: N
LIVANOVA INSPIRE 8S
MDR report key: 10301745
·
Received July 21, 2020
Report
- Report Number
- 10301745
- Event Type
- Malfunction
- Date Received
- July 21, 2020
- Date of Event
- July 8, 2020
- Report Date
- July 16, 2020
- Manufacturer
- SORIN GROUP ITALIA SRL
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
OXYGENATOR LEAKED DROPS OF BLOOD DURING PROCEDURE.
Description of Event or Problem · 1
OXYGENATOR LEAKED DROPS OF BLOOD DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767409 | LIVANOVA INSPIRE 8S | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA SRL | 20036000026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23360 DA |