FDA Adverse Event
Malfunction
Summary report: N
HSR-4000 GOLD
MDR report key: 127693
·
Received October 17, 1997
Report
- Report Number
- 6000002-1997-00772
- Event Type
- Malfunction
- Date Received
- October 17, 1997
- Report Date
- September 29, 1997
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- DTN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DURING BYPASS, THE BLOOD OUTLET PORT OF THE VENOUS RESERVOIR WAS DETACHED. THERE WAS NO PT INJURY OR INTERVENTION REPORTED AS THE RESULT OF THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HSR-4000 GOLD | VENOUS RESERVOIR | DTN | BAXTER HEALTHCARE CORP. | HSR-4000 GOLD | PP7C2460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |