FDA Adverse Event
Death
Summary report: N
CRESCENT JUGULAR DUAL LUMEN
MDR report key: 10521334
·
Received September 7, 2020
Report
- Report Number
- 10521334
- Event Type
- Death
- Date Received
- September 7, 2020
- Date of Event
- August 21, 2020
- Report Date
- September 4, 2020
- Manufacturer
- MC3 CARDIOPULMONARY
- Product Code
- PZS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 1
BREAK IN CRESCENT ECMO CATHETER INSERTED AT ANOTHER HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 964660 | CRESCENT JUGULAR DUAL LUMEN | ECMO CANNULA | PZS | MC3 CARDIOPULMONARY | 70128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Death |