| Device Type ID | 801 |
| Device Name | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Regulation Description | Roller-type Cardiopulmonary Bypass Blood Pump. |
| 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 | 870.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 801 |
| Device | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Product Code | DWB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Roller-type Cardiopulmonary Bypass Blood Pump. |
| CFR Regulation Number | 870.4370 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Display / Image | 246 |
Device Displays Incorrect Message | 226 |
Pumping Stopped | 130 |
Device Operational Issue | 59 |
Pump | 57 |
Failure To Pump | 47 |
Display Or Visual Feedback Problem | 41 |
Appropriate Term/Code Not Available | 33 |
Device Operates Differently Than Expected | 28 |
Potentiometer | 21 |
Break | 19 |
Pumping Problem | 18 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 17 |
Alarm | 12 |
Detachment Of Device Component | 12 |
Mechanical Problem | 11 |
Output Problem | 9 |
Loss Of Power | 9 |
Failure To Power Up | 9 |
Device Issue | 7 |
Image Display Error / Artifact | 7 |
Magnet | 7 |
Failure To Auto Stop | 7 |
False Alarm | 7 |
Device Stops Intermittently | 7 |
Mechanical Jam | 6 |
Display | 5 |
Device Alarm System | 4 |
Device Markings / Labelling Problem | 4 |
Positioning Problem | 4 |
Knob | 4 |
Connection Problem | 4 |
No Flow | 3 |
Suction Problem | 3 |
Component Missing | 3 |
Incorrect Measurement | 3 |
Decreased Pump Speed | 3 |
Power Problem | 3 |
Communication Or Transmission Problem | 3 |
Alarm Not Visible | 3 |
Insufficient Flow Or Under Infusion | 3 |
Crack | 3 |
Detachment Of Device Or Device Component | 3 |
Overheating Of Device | 2 |
Encoder | 2 |
Increased Pump Speed | 2 |
Noise, Audible | 2 |
Switch, Push Button | 2 |
Erratic Or Intermittent Display | 2 |
Loose Or Intermittent Connection | 2 |
Sticking | 2 |
Material Deformation | 2 |
Protective Measures Problem | 2 |
Ring | 2 |
Human Factors Issue | 2 |
Unexpected Shutdown | 2 |
Fracture | 2 |
Infusion Or Flow Problem | 2 |
Display Difficult To Read | 2 |
Alarm, Visual | 2 |
LED (Light Emitting Diode) | 2 |
Physical Property Issue | 2 |
Screw | 1 |
Bearings | 1 |
No Audible Alarm | 1 |
Difficult To Open Or Close | 1 |
Use Of Device Problem | 1 |
Fail-Safe Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Device Contamination With Body Fluid | 1 |
Device Sensing Problem | 1 |
Improper Device Output | 1 |
Operating System Becomes Nonfunctional | 1 |
Physical Resistance | 1 |
Tube | 1 |
Device Handling Problem | 1 |
Use Of Incorrect Control Settings | 1 |
Physical Resistance / Sticking | 1 |
Leak / Splash | 1 |
Decrease In Pressure | 1 |
Moisture Damage | 1 |
Material Rupture | 1 |
Volume Accuracy Problem | 1 |
Alarm, Audible | 1 |
Alarm, Pressure | 1 |
Hinge | 1 |
Difficult To Advance | 1 |
Defective Alarm | 1 |
Thermal Decomposition Of Device | 1 |
Temperature Problem | 1 |
Insufficient Information | 1 |
Power Switch | 1 |
Fluid Leak | 1 |
Difficult To Position | 1 |
Device Slipped | 1 |
Failure To Shut Off | 1 |
Improper Flow Or Infusion | 1 |
Calibration Problem | 1 |
| Total Device Problems | 1186 |