| Device Type ID | 804 |
| Device Name | Tubing, Pump, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Pump Tubing. |
| 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 | 870.4390 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWE |
| 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 | 804 |
| Device | Tubing, Pump, Cardiopulmonary Bypass |
| Product Code | DWE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Pump Tubing. |
| CFR Regulation Number | 870.4390 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIODYNAMICS COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 57 |
Fluid Leak | 47 |
Device Operates Differently Than Expected | 29 |
Defective Component | 17 |
Filtration Problem | 16 |
Improper Flow Or Infusion | 15 |
Device Misassembled During Manufacturing / Shipping | 10 |
Misassembled | 8 |
Infusion Or Flow Problem | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Material Fragmentation | 5 |
Pumping Problem | 5 |
Packaging Problem | 5 |
Restricted Flow Rate | 5 |
Kinked | 5 |
Malfunction | 5 |
Loose Or Intermittent Connection | 4 |
Noise, Audible | 4 |
Crack | 4 |
Detachment Of Device Component | 4 |
Use Of Device Problem | 4 |
No Flow | 3 |
Device Displays Incorrect Message | 3 |
Material Discolored | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Air Leak | 3 |
Blocked Connection | 3 |
Disconnection | 3 |
Device Damaged Prior To Use | 2 |
Device Markings / Labelling Problem | 2 |
Component(s), Broken | 2 |
Pumping Stopped | 2 |
Off-Label Use | 2 |
Tube | 2 |
Pressure Problem | 2 |
Decoupling | 2 |
Port | 2 |
Labeling, Missing | 2 |
Cap | 2 |
Fracture | 2 |
Connection Problem | 2 |
Jaw | 2 |
No Apparent Adverse Event | 2 |
Luer Valve | 2 |
Particulates | 2 |
Shipping Damage Or Problem | 2 |
Tube(s), Splitting Of | 1 |
Loss Of Or Failure To Bond | 1 |
Incorrect Measurement | 1 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Difficult To Open Or Close | 1 |
Appropriate Term/Code Not Available | 1 |
Physical Property Issue | 1 |
Shaft | 1 |
Delivered As Unsterile Product | 1 |
Occlusion Within Device | 1 |
Laser Pulse Timing Error | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Clumping In Device Or Device Ingredient | 1 |
Misconnection | 1 |
Device Contamination With Body Fluid | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Device Sensing Problem | 1 |
Improper Device Output | 1 |
One-Way Valve | 1 |
Sticking | 1 |
Transducer | 1 |
Coil | 1 |
Inadequate Or Insufficient Training | 1 |
Misassembly By Users | 1 |
Complete Blockage | 1 |
False Device Output | 1 |
Unsealed Device Packaging | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Defective Device | 1 |
No Device Output | 1 |
Filter | 1 |
Break | 1 |
Torn Material | 1 |
Output Problem | 1 |
Free Or Unrestricted Flow | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Mechanics Altered | 1 |
Failure To Analyze Signal | 1 |
| Total Device Problems | 360 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics Inc. (Navilyst Medical Inc.) | II | May-20-2016 |
| 2 | Datascope Corporation | II | Oct-11-2018 |
| 3 | Datascope Corporation | III | Jun-06-2018 |
| 4 | Datascope Corporation | II | May-08-2018 |
| 5 | Datascope Corporation | II | Mar-23-2017 |
| 6 | Datascope Corporation | II | Jun-15-2016 |
| 7 | LivaNova USA | III | Feb-21-2018 |
| 8 | Maquet | II | Dec-20-2017 |
| 9 | Medtronic Inc. Cardiac Rhythm Disease Management | II | Feb-20-2014 |
| 10 | Medtronic Perfusion Systems | II | Sep-04-2015 |
| 11 | Sorin Group USA, Inc. | II | Jul-29-2017 |