| Device Type ID | 794 |
| Device Name | Heat-exchanger, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Heat Exchanger. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4240 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 794 |
| Device | Heat-exchanger, Cardiopulmonary Bypass |
| Product Code | DTR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Heat Exchanger. |
| CFR Regulation Number | 870.4240 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATRION CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUEST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 62 |
Leak / Splash | 51 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 15 |
Device Sensing Problem | 12 |
Device Displays Incorrect Message | 12 |
No Apparent Adverse Event | 9 |
Air Leak | 8 |
Nonstandard Device | 6 |
Solder Joint Fracture | 6 |
Failure To Prime | 5 |
Device Operates Differently Than Expected | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Moisture Damage | 4 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Loss Of Or Failure To Bond | 3 |
Component Missing | 3 |
Appropriate Term/Code Not Available | 2 |
Burst Container Or Vessel | 2 |
Infusion Or Flow Problem | 2 |
Valve | 2 |
Complete Loss Of Power | 2 |
Defective Device | 2 |
Electromagnetic Interference | 2 |
Cassette | 2 |
Device Issue | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Detachment Of Device Component | 1 |
Sticking | 1 |
Tube | 1 |
Hole In Material | 1 |
Excess Flow Or Over-Infusion | 1 |
Output Problem | 1 |
Split | 1 |
Shelf Life Exceeded | 1 |
Filter | 1 |
Crack | 1 |
Display Or Visual Feedback Problem | 1 |
Positioning Problem | 1 |
Connector | 1 |
Sensor | 1 |
Loose Or Intermittent Connection | 1 |
Failure To Adhere Or Bond | 1 |
Decoupling | 1 |
Electronic Property Issue | 1 |
Power Problem | 1 |
Foreign Material | 1 |
Device Operational Issue | 1 |
Material Split, Cut Or Torn | 1 |
Luer Valve | 1 |
Stopcock | 1 |
Failure To Deliver | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
No Flow | 1 |
Degraded | 1 |
Particulates | 1 |
Use Of Device Problem | 1 |
Circuit Failure | 1 |
Insufficient Cooling | 1 |
Occlusion Within Device | 1 |
Increase In Pressure | 1 |
Self-Activation Or Keying | 1 |
| Total Device Problems | 263 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet Cardiovascular Us Sales, Llc | II | Mar-10-2014 |
| 2 | Quest Medical, Inc. | II | Dec-02-2015 |
| 3 | Terumo Cardiovascular Systems Corp | II | Oct-31-2014 |