Definition: If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
| Device Type ID | 802 |
| Device Name | Controller, Temperature, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Temperature Controller. |
| 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 | 870.4250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 802 |
| Device | Controller, Temperature, Cardiopulmonary Bypass |
| Product Code | DWC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Temperature Controller. |
| CFR Regulation Number | 870.4250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP DEUTSCHLAND GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 777 |
Device Displays Incorrect Message | 346 |
Adverse Event Without Identified Device Or Use Problem | 137 |
Insufficient Heating | 106 |
Electrical /Electronic Property Problem | 98 |
Device Operates Differently Than Expected | 95 |
Appropriate Term/Code Not Available | 94 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 91 |
Insufficient Cooling | 81 |
Temperature Problem | 63 |
Fluid Leak | 46 |
Device Stops Intermittently | 38 |
Valve, Flow | 37 |
Insufficient Information | 30 |
Leak / Splash | 27 |
Electrical Shorting | 26 |
Thermal Decomposition Of Device | 20 |
Noise, Audible | 19 |
Device Issue | 18 |
Device Operational Issue | 18 |
Improper Flow Or Infusion | 17 |
Pumping Problem | 16 |
Failure To Power Up | 16 |
Biofilm Coating In Device | 16 |
No Flow | 15 |
Failure To Pump | 14 |
Infusion Or Flow Problem | 13 |
Loss Of Power | 13 |
Overheating Of Device | 13 |
Mechanical Problem | 13 |
Device Alarm System | 11 |
Device Contamination With Biological Material | 10 |
Device Inoperable | 10 |
No Display / Image | 10 |
Contamination During Use | 8 |
Fuse | 8 |
Pump | 8 |
Pumping Stopped | 8 |
Partial Blockage | 7 |
Device Contamination With Chemical Or Other Material | 7 |
Power Problem | 7 |
Device Reprocessing Problem | 7 |
Connection Problem | 7 |
Smoking | 6 |
Use Of Device Problem | 6 |
Display Or Visual Feedback Problem | 6 |
Impedance Problem | 5 |
Defective Component | 5 |
Corroded | 4 |
Metal Shedding Debris | 4 |
Melted | 4 |
Electrical Power Problem | 4 |
Switches | 4 |
Device Disinfection Or Sterilization Issue | 4 |
Loose Or Intermittent Connection | 4 |
Connector | 4 |
Break | 4 |
Heater | 4 |
Alarm, LED | 4 |
Compressor (Air Pump) | 4 |
Failure To Disinfect | 3 |
Device Handling Problem | 3 |
Pressure Problem | 3 |
Motor | 3 |
Resistor | 3 |
Alarm, Audible | 3 |
Restricted Flow Rate | 3 |
Circuit Failure | 3 |
Failure To Calibrate | 3 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 3 |
Circuit Breaker | 3 |
False Alarm | 3 |
Electronic Property Issue | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Material Integrity Problem | 3 |
Tee | 3 |
Calcified | 2 |
Failure To Prime | 2 |
PC (Printed Circuit) Board | 2 |
Valve | 2 |
Misconnection | 2 |
Obstruction Of Flow | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 2 |
Mixer | 2 |
Occlusion Within Device | 2 |
Temperature Sensor | 2 |
Insufficient Flow Or Under Infusion | 2 |
Device Damaged Prior To Use | 2 |
Failure To Run On AC/DC | 2 |
Low Audible Alarm | 2 |
No Device Output | 2 |
Calibration Problem | 2 |
Failure To Shut Off | 2 |
Valve, Control | 2 |
Plug | 2 |
Knob | 2 |
Misassembly By Users | 2 |
Relay | 2 |
Complete Blockage | 1 |
| Total Device Problems | 2592 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cincinnati Sub-Zero Products Inc | II | Apr-15-2017 |
| 2 | Cincinnati Sub-Zero Products LLC | II | Feb-13-2018 |
| 3 | Cincinnati Sub-Zero Products LLC, A Gentherm Company | II | Feb-13-2019 |
| 4 | Cincinnati Sub-Zero Products LLC, A Gentherm Company | II | Oct-03-2018 |
| 5 | LivaNova USA | II | May-18-2018 |
| 6 | Maquet Cardiovascular Us Sales, Llc | II | Nov-03-2016 |
| 7 | Maquet Cardiovascular Us Sales, Llc | II | Jan-05-2016 |
| 8 | Sorin Group USA, Inc. | II | Jul-25-2017 |
| 9 | Sorin Group USA, Inc. | II | Dec-01-2016 |
| 10 | Sorin Group USA, Inc. | II | Mar-17-2016 |
| 11 | Sorin Group USA, Inc. | II | Jul-15-2015 |
| 12 | Terumo Cardiovascular Systems Corporation | II | Apr-18-2018 |
| 13 | Terumo Cardiovascular Systems Corporation | II | Jul-14-2016 |
| 14 | Terumo Cardiovascular Systems Corporation | II | Jun-26-2015 |
| 15 | Terumo Cardiovascular Systems Corporation | II | Feb-13-2015 |