| Device Type ID | 847 |
| Device Name | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Regulation Description | Nonroller-type 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 | 870.4360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KFM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 847 |
| Device | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Product Code | KFM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonroller-type Blood Pump. |
| CFR Regulation Number | 870.4360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTERNATIONAL BIOPHYSICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Noise, Audible | 195 |
Pumping Stopped | 99 |
Pumping Problem | 84 |
Device Displays Incorrect Message | 70 |
Leak / Splash | 63 |
Battery Problem | 42 |
Device Operates Differently Than Expected | 40 |
Power Problem | 35 |
Fluid Leak | 31 |
Overheating Of Device | 30 |
Infusion Or Flow Problem | 30 |
Adverse Event Without Identified Device Or Use Problem | 30 |
Battery | 27 |
Device Stops Intermittently | 26 |
No Display / Image | 25 |
No Flow | 20 |
Use Of Device Problem | 14 |
Mechanical Problem | 14 |
Device Operational Issue | 11 |
Insufficient Flow Or Under Infusion | 10 |
Low Battery | 10 |
Fuse | 9 |
Suction Problem | 9 |
Air Leak | 7 |
Break | 7 |
Crack | 6 |
Improper Flow Or Infusion | 6 |
Loss Of Power | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Failure To Charge | 6 |
Failure To Run On Battery | 5 |
Device Inoperable | 5 |
Decoupling | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Charging Problem | 4 |
Communication Or Transmission Problem | 4 |
Decreased Pump Speed | 4 |
Alarm Not Visible | 4 |
Device Issue | 4 |
No Device Output | 4 |
Insufficient Information | 3 |
Device Alarm System | 3 |
Out-Of-Box Failure | 3 |
Alarm, LED | 3 |
Pump | 3 |
Detachment Of Device Component | 3 |
Electrical /Electronic Property Problem | 3 |
Fracture | 3 |
Defective Component | 3 |
Failure To Adhere Or Bond | 3 |
False Alarm | 2 |
Vibration | 2 |
Failure To Prime | 2 |
Premature Discharge Of Battery | 2 |
No Audible Alarm | 2 |
Incorrect Measurement | 2 |
Material Deformation | 2 |
Failure To Power Up | 2 |
Material Separation | 2 |
Thermal Decomposition Of Device | 2 |
Disconnection | 2 |
Unable To Obtain Readings | 2 |
Device Damaged Prior To Use | 2 |
Sensor | 2 |
Packaging Problem | 2 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 2 |
Material Perforation | 1 |
Detachment Of Device Or Device Component | 1 |
Temperature Problem | 1 |
Failure To Run On AC/DC | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Display Or Visual Feedback Problem | 1 |
Nonstandard Device | 1 |
Connector | 1 |
Difficult To Advance | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Restricted Flow Rate | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Carbon Absorption | 1 |
Failure To Conduct | 1 |
Decrease In Suction | 1 |
Inadequate Or Insufficient Training | 1 |
Off-Label Use | 1 |
Positioning Failure | 1 |
Protective Measures Problem | 1 |
Pressure Problem | 1 |
Motor | 1 |
Image Display Error / Artifact | 1 |
Partial Blockage | 1 |
Decrease In Pressure | 1 |
Sharp/jagged/rough/etched/scratched | 1 |
Electrical Shorting | 1 |
Particulates | 1 |
Device Difficult To Setup Or Prepare | 1 |
Failure To Pump | 1 |
Shipping Damage Or Problem | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 |
Coagulation In Device Or Device Ingredient | 1 |
| Total Device Problems | 1108 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet Cardiovascular Us Sales, Llc | II | Apr-12-2016 |
| 2 | Terumo Cardiovascular Systems Corporation | II | Feb-22-2017 |
| 3 | Terumo Cardiovascular Systems Corporation | II | Jul-11-2014 |
| 4 | Thoratec Switzerland GMBH | II | Oct-12-2018 |