FDA Adverse Event
Other
Summary report: N
UVAR XTS
MDR report key: 909497
·
Received September 7, 2007
Report
- Report Number
- 2523595-2007-00007
- Event Type
- Other
- Date Received
- September 7, 2007
- Date of Event
- August 17, 2007
- Report Date
- August 29, 2007
- Manufacturer
- THERAKOS, INC.
- Product Code
- LNR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
Narratives
Description of Event or Problem · 1
THIS CASE CONCERNS A PATIENT RECEIVING EXTRACORPOREAL PHOTOPHERESIS TREATMENTS. SHE HAD BEEN RECEIVING ECP TREATMENTS ON A CYCLE OF TWO TREATMENTS EVERY FIFTEEN DAYS. THE TREATING PHYSICIANS ELECTED TO DISCONTINUE THIS ECP TREATMENT FOR THIS PATIENT AFTER TWO CYCLES AND THE BLOOD WAS NOT RETURNED DUE TO POOR VENOUS ACCESS (POOR QUALITY VEINS DUE TO THE OVERALL POOR HEALTH OF THE PATIENT). THE ESTIMATED BLOOD LOSS WAS APPROX 500 ML. NO ADDITIONAL MEDICAL THERAPY WAS ADMINISTERED FOR THE PATIENT AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UVAR XTS | XT125 PHOTOPHERESIS KIT | LNR | THERAKOS, INC. | XT125 | V708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |