| Device Type ID | 800 |
| Device Name | Control, Pump Speed, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Pump Speed Control. |
| 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 | 870.4380 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 800 |
| Device | Control, Pump Speed, Cardiopulmonary Bypass |
| Product Code | DWA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Pump Speed Control. |
| CFR Regulation Number | 870.4380 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 96 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 86 |
No Display / Image | 74 |
Pumping Stopped | 73 |
Device Displays Incorrect Message | 50 |
Device Stops Intermittently | 32 |
Noise, Audible | 32 |
Overheating Of Device | 25 |
Device Operational Issue | 24 |
Decreased Pump Speed | 21 |
Infusion Or Flow Problem | 20 |
Power Problem | 18 |
Device Operates Differently Than Expected | 16 |
No Flow | 16 |
Insufficient Information | 13 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 12 |
Pumping Problem | 12 |
Break | 11 |
Communication Or Transmission Problem | 11 |
Display Or Visual Feedback Problem | 9 |
Inaccurate Flow Rate | 8 |
Smoking | 8 |
Appropriate Term/Code Not Available | 7 |
Device Alarm System | 7 |
Insufficient Flow Or Under Infusion | 7 |
Loss Of Power | 7 |
Device Issue | 7 |
Pump | 6 |
Use Of Device Problem | 6 |
Electrical /Electronic Property Problem | 6 |
Latch | 5 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Physical Property Issue | 5 |
Battery Problem | 5 |
Visual Prompts Will Not Clear | 5 |
Sensor | 5 |
Thermal Decomposition Of Device | 5 |
No Device Output | 5 |
Temperature Problem | 4 |
Improper Flow Or Infusion | 4 |
Loose Or Intermittent Connection | 4 |
Failure To Power Up | 4 |
Failure To Pump | 4 |
Maintenance Does Not Comply To Manufacturers Recommendations | 4 |
Invalid Sensing | 4 |
Connection Problem | 3 |
Battery | 3 |
Device Inoperable | 3 |
Vibration | 3 |
Knob | 3 |
Output Problem | 3 |
Display | 2 |
Unable To Obtain Readings | 2 |
Low Battery | 2 |
Positioning Problem | 2 |
Erratic Or Intermittent Display | 2 |
Alarm | 2 |
Improper Device Output | 2 |
Material Twisted / Bent | 2 |
Electrical Power Problem | 2 |
Inappropriate Or Unexpected Reset | 2 |
No Apparent Adverse Event | 2 |
Device Dislodged Or Dislocated | 1 |
Bearings | 1 |
Failure To Charge | 1 |
Material Split, Cut Or Torn | 1 |
Premature Discharge Of Battery | 1 |
Circuit Failure | 1 |
Failure To Run On Battery | 1 |
Self-Activation Or Keying | 1 |
Human-Device Interface Problem | 1 |
Cable | 1 |
PC (Printed Circuit) Board | 1 |
Failure To Sense | 1 |
Issue With Displayed Error Message | 1 |
Material Integrity Problem | 1 |
Electro-Static Discharge | 1 |
Defective Component | 1 |
Low Readings | 1 |
Device Sensing Problem | 1 |
Alarm, Audible | 1 |
Alarm, Pressure | 1 |
Defective Alarm | 1 |
Restricted Flow Rate | 1 |
Disconnection | 1 |
Malposition Of Device | 1 |
Power Switch | 1 |
Encoder | 1 |
Failure To Run On AC/DC | 1 |
Crack | 1 |
Nonstandard Device | 1 |
Increased Pump Speed | 1 |
Incorrect Or Inadequate Test Results | 1 |
Detachment Of Device Or Device Component | 1 |
Alarm Not Visible | 1 |
Image Display Error / Artifact | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Failure Of Device To Self-Test | 1 |
No Pressure | 1 |
Motor Drive Unit | 1 |
| Total Device Problems | 866 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sorin Group Deutschland GmbH | II | Jan-19-2018 |
| 2 | Sorin Group Deutschland GmbH | II | Jan-28-2014 |