FDA Adverse Event
Other
Summary report: N
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
MDR report key: 1962900
·
Received January 13, 2011
Report
- Report Number
- 2523595-2011-00001
- Event Type
- Other
- Date Received
- January 13, 2011
- Date of Event
- December 28, 2010
- Report Date
- January 13, 2011
- Manufacturer
- THERAKOS, INC.
- Product Code
- LNR
- PMA / PMN Number
- P860003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN RECEIVED TO DATE. (B)(4). ON (B)(4) 2011, PATIENT EXPERIENCED AGONAL BREATHING. PHYSICIAN WAS CALLED. CARDIAC MONITORING REVEALED TACHYCARDIA; PATIENT WAS INTUBATED AND TRANSFERRED TO CCMU. CT SCAN SHOWED MASSIVE INTRACRANIAL HEMORRHAGE WITH LITTLE CHANCE OF RECOVERY. FAMILY MADE DECISION TO EXTUBATE AND PATIENT DIED (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
PATIENT WAS CURRENTLY UNDERGOING ECP TREATMENT #8 AND EXPERIENCED CHEST PAIN/PRESSURE IN THE MID-STERNUM AREA, LATER EPIGASTRIC AREA-8/10 (GR 3). ECP WAS PAUSED AND PULSE OX WAS 100% ON ROOM AIR. EKG OBTAINED, NASAL OXYGEN PLACED FOR COMFORT AND PAIN MEDS GIVEN. WITHIN 25 MINUTES, PAIN HAD RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM | XTS ECP SYSTEM | LNR | THERAKOS, INC. | XTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |