| Device Type ID | 793 |
| Device Name | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Heart-lung Machine Console. |
| 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 | 870.4220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 793 |
| Device | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Product Code | DTQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Heart-lung Machine Console. |
| CFR Regulation Number | 870.4220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MAQUET CARDIOPULMONARY GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 434 |
Device Displays Incorrect Message | 415 |
Device Operates Differently Than Expected | 324 |
Pump | 216 |
No Display / Image | 162 |
Battery | 132 |
Battery Problem | 123 |
Pumping Stopped | 107 |
Device Alarm System | 105 |
Gas Delivery System | 93 |
Sensor | 90 |
Monitor | 86 |
Failure To Calibrate | 79 |
Power Problem | 75 |
Fluid Leak | 75 |
Break | 72 |
Leak / Splash | 66 |
Device Stops Intermittently | 59 |
Display Or Visual Feedback Problem | 53 |
Bubble Detector | 50 |
Display | 47 |
Output Problem | 44 |
Latch | 43 |
False Alarm | 42 |
Device Operational Issue | 40 |
Charging Problem | 35 |
Calibration Problem | 32 |
Detachment Of Device Component | 31 |
Out-Of-Box Failure | 31 |
O2 Sensor | 30 |
Failure To Run On Battery | 30 |
No Flow | 27 |
Adverse Event Without Identified Device Or Use Problem | 26 |
Connection Problem | 25 |
Failure To Power Up | 22 |
Loose Or Intermittent Connection | 22 |
Protective Measures Problem | 21 |
Failure To Charge | 19 |
Device Sensing Problem | 19 |
Appropriate Term/Code Not Available | 18 |
Use Of Device Problem | 18 |
Pumping Problem | 18 |
Mechanical Jam | 18 |
Mechanical Problem | 17 |
Electrical /Electronic Property Problem | 17 |
Inaccurate Flow Rate | 16 |
Infusion Or Flow Problem | 15 |
Improper Flow Or Infusion | 15 |
Erratic Or Intermittent Display | 15 |
Alarm Not Visible | 14 |
Problem With Software Installation | 14 |
Maintenance Does Not Comply To Manufacturers Recommendations | 14 |
Failure To Auto Stop | 13 |
Device Inoperable | 12 |
Loss Of Power | 12 |
Alarm | 12 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 12 |
Insufficient Information | 12 |
Failure To Run On AC/DC | 11 |
Cable | 11 |
Pad | 11 |
Power Supply | 10 |
Material Integrity Problem | 10 |
Thermal Decomposition Of Device | 10 |
Alarm, LED | 10 |
Power Cord | 9 |
Adhesive | 9 |
Noise, Audible | 9 |
No Audible Alarm | 9 |
Loss Of Or Failure To Bond | 9 |
Failure To Pump | 9 |
Incorrect Measurement | 9 |
Component Missing | 9 |
Failure To Adhere Or Bond | 8 |
Bent | 8 |
Fracture | 8 |
Operating System Becomes Nonfunctional | 8 |
Positioning Problem | 8 |
Alarm, Audible | 7 |
Device Slipped | 7 |
Knob | 7 |
Material Deformation | 7 |
Clamp | 7 |
Improper Device Output | 7 |
Electrical Power Problem | 7 |
High Readings | 6 |
Electronic Property Issue | 6 |
Failure To Sense | 6 |
Device Issue | 6 |
Detachment Of Device Or Device Component | 6 |
No Device Output | 6 |
Filtration Problem | 5 |
Calibration Error | 5 |
Insufficient Flow Or Under Infusion | 5 |
Pressure Problem | 5 |
Electrical Shorting | 5 |
Improper Alarm | 5 |
Sensing Intermittently | 5 |
Communication Or Transmission Problem | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
| Total Device Problems | 3999 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet Cardiovascular Us Sales, Llc | I | Mar-28-2019 |
| 2 | Maquet Cardiovascular Us Sales, Llc | II | Apr-12-2016 |
| 3 | Maquet Cardiovascular Us Sales, Llc | II | May-28-2015 |
| 4 | Maquet Cardiovascular Us Sales, Llc | II | Nov-13-2014 |
| 5 | Sorin Group Deutschland GmbH | II | Jan-28-2014 |
| 6 | Sorin Group USA, Inc. | II | Sep-21-2016 |
| 7 | Terumo Cardiovascular Systems Corporation | II | Oct-18-2018 |
| 8 | Terumo Cardiovascular Systems Corporation | II | Sep-25-2018 |
| 9 | Terumo Cardiovascular Systems Corporation | II | Apr-20-2018 |
| 10 | Terumo Cardiovascular Systems Corporation | II | Mar-14-2017 |
| 11 | Terumo Cardiovascular Systems Corporation | II | May-28-2015 |
| 12 | Terumo Cardiovascular Systems Corporation | II | Jul-08-2014 |