| Device Type ID | 2197 |
| Device Name | System, Photopheresis, Extracorporeal |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LNR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2197 |
| Device | System, Photopheresis, Extracorporeal |
| Product Code | LNR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 75 |
Leak / Splash | 32 |
Device Displays Incorrect Message | 29 |
Fluid Leak | 24 |
Break | 15 |
Tube | 8 |
Air Leak | 7 |
Noise, Audible | 4 |
Device Alarm System | 4 |
Loose Or Intermittent Connection | 2 |
Malposition Of Device | 2 |
Free Or Unrestricted Flow | 2 |
Split | 2 |
Insufficient Information | 2 |
Missing Value Reason | 2 |
Hole In Material | 2 |
Dome | 2 |
Occlusion Within Device | 2 |
Fracture | 2 |
Difficult To Remove | 1 |
Bent | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Device Contamination With Body Fluid | 1 |
Increase In Pressure | 1 |
Reservoir | 1 |
Obstruction Of Flow | 1 |
Device Dislodged Or Dislocated | 1 |
Misassembly By Users | 1 |
Clip | 1 |
Crack | 1 |
Lens Washers, Failure Of | 1 |
Stretched | 1 |
Insufficient Flow Or Under Infusion | 1 |
Disconnection | 1 |
| Total Device Problems | 234 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Therakos Inc | II | Apr-05-2016 |