FDA Adverse Event
Other
Summary report: N
SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
MDR report key: 1325570
·
Received February 13, 2009
Report
- Report Number
- 2015691-2009-09901
- Event Type
- Other
- Date Received
- February 13, 2009
- Date of Event
- December 3, 2008
- Report Date
- January 20, 2009
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- PMA / PMN Number
- K812563
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NURSE TRIED TO WEDGE THE CATHETER, THE SYRINGE PLUNGER WENT ALL THE WAY IN WITH NO WEDGE AND THEN FAILED TO RETRACT OR WITHDRAW ON ITS OWN. WHEN PULLING BACK THE PLUNGER, THERE WAS BLOOD IN THE SYRINGE. THE PT BECAME TACHYPNEIC BUT THE OXYGEN SATURATIONS STAYED IN THE 90'S. A CHEST X-RAY, ABGS, AND A CBC WERE DONE. THE PT'S RESPIRATIONS FINALLY WENT TO THE 20S AND THE PT WAS MORE COMFORTABLE. IT WAS FURTHER REPORTED THAT A CHEST X-RAY WAS PERFORMED IN 2008: AFTER INCIDENT: CHEST X-RAY - CVC IS IN PLACE WITH THE TIP OF THE CATHETER IN THE SUPERIOR VENA CAVA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER | THERMODILUTION VIP CATHETER | DYG | EDWARDS LIFESCIENCES, PR | 831HF75 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |