FDA Adverse Event
Malfunction
Summary report: N
TERUMO SARNS
MDR report key: 3073147
·
Received April 16, 2013
Report
- Report Number
- 3073147
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- January 24, 2013
- Report Date
- April 16, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DWC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164247 | TERUMO SARNS | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP | TCM II | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |