| Device Type ID | 2192 |
| Device Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LKN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2192 |
| Device | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Product Code | LKN |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS KABI AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRESENIUS KABI USA LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO BCT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO BCT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Inadequate User Interface | 155 |
Data Problem | 120 |
Adverse Event Without Identified Device Or Use Problem | 119 |
Improper Or Incorrect Procedure Or Method | 51 |
Excess Flow Or Over-Infusion | 38 |
Incorrect Software Programming Calculations | 35 |
Device Displays Incorrect Message | 26 |
Patient Data Problem | 24 |
Device Operational Issue | 17 |
Insufficient Information | 14 |
Programming Issue | 13 |
Use Of Device Problem | 13 |
Device Operates Differently Than Expected | 10 |
Occlusion Within Device | 6 |
Nonstandard Device | 6 |
Fluid Leak | 5 |
Air Leak | 5 |
Patient-Device Incompatibility | 5 |
Defective Component | 4 |
Device Misassembled During Manufacturing / Shipping | 4 |
Insufficient Flow Or Under Infusion | 4 |
Device Disinfection Or Sterilization Issue | 4 |
Component Falling | 3 |
Contamination Of Device Ingredient Or Reagent | 3 |
Tube | 3 |
Clamp | 2 |
Pump | 2 |
Misassembly By Users | 2 |
Partial Blockage | 2 |
Detachment Of Device Component | 2 |
Incomplete Or Inadequate Connection | 2 |
Disconnection | 2 |
Device Alarm System | 2 |
Break | 2 |
Shelf Life Exceeded | 2 |
Detachment Of Device Or Device Component | 2 |
Unexpected Therapeutic Results | 2 |
Device Inoperable | 2 |
False Reading From Device Non-Compliance | 2 |
High Test Results | 2 |
Label | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Misassembled | 1 |
Contamination / Decontamination Problem | 1 |
Connection Problem | 1 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Failure To Calibrate | 1 |
Difficult To Open Or Close | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Infusion Or Flow Problem | 1 |
Clumping In Device Or Device Ingredient | 1 |
Contamination During Use | 1 |
Material Discolored | 1 |
Device Sensing Problem | 1 |
Improper Device Output | 1 |
Bubble Detector | 1 |
Improper Flow Or Infusion | 1 |
Inadequate Instructions For Non-Healthcare Professional | 1 |
Incorrect Or Inadequate Test Results | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Temperature Problem | 1 |
Connector | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Leak / Splash | 1 |
Accessory Incompatible | 1 |
Use Of Incorrect Control Settings | 1 |
Material Separation | 1 |
Device Damaged By Another Device | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 750 |