| Device Type ID | 762 |
| Device Name | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass On-line Blood Gas Monitor. |
| 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 | 870.4330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 762 |
| Device | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Product Code | DRY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass On-line Blood Gas Monitor. |
| CFR Regulation Number | 870.4330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPECTRUM MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Leak / Splash | 236 |
Monitor | 148 |
Connection Problem | 137 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 90 |
Incorrect Or Inadequate Test Results | 83 |
Fluid Leak | 30 |
Incorrect Measurement | 13 |
Device Operates Differently Than Expected | 11 |
High Readings | 10 |
Capacitor | 10 |
Thermal Decomposition Of Device | 10 |
Device Displays Incorrect Message | 7 |
Electrical /Electronic Property Problem | 6 |
Nonstandard Device | 6 |
Impedance Problem | 5 |
Smoking | 5 |
High Test Results | 4 |
Battery | 4 |
Corroded | 3 |
PC (Printed Circuit) Board | 3 |
Circuit Failure | 3 |
No Display / Image | 3 |
Overheating Of Device | 3 |
Calibration Problem | 3 |
Low Test Results | 3 |
Failure To Power Up | 3 |
Device Emits Odor | 2 |
Probe | 2 |
Crack | 2 |
No Device Output | 2 |
Device Inoperable | 2 |
Low Readings | 2 |
Battery Problem | 1 |
Power Conditioning Problem | 1 |
Infusion Or Flow Problem | 1 |
Failure To Calibrate | 1 |
Resistance, Loss Of | 1 |
Power Supply | 1 |
Lenses | 1 |
No Audible Alarm | 1 |
Failure To Run On Battery | 1 |
Display Or Visual Feedback Problem | 1 |
Charred | 1 |
Temperature Problem | 1 |
Noise, Audible | 1 |
Sensor | 1 |
Device Alarm System | 1 |
Calibration Error | 1 |
Imprecision | 1 |
Loose Or Intermittent Connection | 1 |
Out-Of-Box Failure | 1 |
Device Issue | 1 |
Electrical Shorting | 1 |
| Total Device Problems | 872 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Terumo Cardiovascular Systems Corporation | II | Aug-11-2018 |
| 2 | Terumo Cardiovascular Systems Corporation | III | Oct-03-2016 |
| 3 | Terumo Cardiovascular Systems Corporation | II | Mar-25-2016 |
| 4 | Terumo Cardiovascular Systems Corporation | II | Sep-09-2015 |
| 5 | Terumo Cardiovascular Systems Corporation | II | May-19-2014 |