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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oxygenator, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass oxygenator.
Product CodeDTZ
Regulation Number 870.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHALICE MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 3
EUROSETS S.R.L
  SUBSTANTIALLY EQUIVALENT 4
LIFEMOTION MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
QURA S.R.L
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SPECTRUM MEDICAL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 442 443
2021 595 595
2022 559 560
2023 738 739
2024 535 536
2025 987 987
2026 571 571

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1194 1194
Leak/Splash 345 345
Increase in Pressure 339 339
Gas Output Problem 261 261
Break 187 187
Obstruction of Flow 171 172
Infusion or Flow Problem 171 171
Material Separation 162 162
Pressure Problem 146 147
Packaging Problem 130 130
Use of Device Problem 128 128
Crack 125 125
Air/Gas in Device 120 120
Material Deformation 100 100
Delivered as Unsterile Product 69 69
Noise, Audible 68 68
Adverse Event Without Identified Device or Use Problem 64 64
Mechanical Problem 59 59
Coagulation in Device or Device Ingredient 58 58
Material Puncture/Hole 56 56
Insufficient Information 55 55
Unexpected Therapeutic Results 47 47
Failure to Deliver 46 46
Defective Component 44 44
Detachment of Device or Device Component 42 42
Gas/Air Leak 40 41
Contamination 39 39
Improper Chemical Reaction 35 35
Manufacturing, Packaging or Shipping Problem 34 34
Shipping Damage or Problem 32 32
Decrease in Pressure 32 33
Insufficient Flow or Under Infusion 30 30
Improper Flow or Infusion 29 29
Contamination /Decontamination Problem 25 25
Connection Problem 23 23
Disconnection 23 23
Fracture 22 22
Partial Blockage 21 21
Medical Gas Supply Problem 20 20
Device Sensing Problem 19 19
No Flow 19 19
Defective Device 16 16
Output Problem 16 16
Temperature Problem 15 15
Low Readings 14 14
Pumping Stopped 14 14
Loose or Intermittent Connection 14 14
Particulates 13 13
High Readings 12 12
Scratched Material 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3457 3461
Hemorrhage/Bleeding 290 290
No Patient Involvement 176 176
No Consequences Or Impact To Patient 173 173
Insufficient Information 158 159
No Known Impact Or Consequence To Patient 61 61
Low Oxygen Saturation 56 56
Cardiac Arrest 34 34
Hypoxia 34 34
Death 26 26
Blood Loss 25 25
Low Blood Pressure/ Hypotension 23 23
Hemolysis 18 18
Sepsis 17 17
No Information 17 17
Thrombosis/Thrombus 16 16
Air Embolism 12 12
Coagulation Disorder 10 10
Abnormal Blood Gases 9 9
Anemia 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Stroke/CVA 8 8
Unspecified Infection 8 8
Injury 7 7
Respiratory Failure 5 5
Ischemia Stroke 5 5
Pneumonia 5 5
Ischemia 5 5
Brain Injury 4 4
Bradycardia 4 4
Asystole 4 4
Thrombocytopenia 4 4
Tachycardia 4 4
Septic Shock 4 4
Hematoma 3 3
Lactate Dehydrogenase Increased 3 3
Hypothermia 3 3
Renal Failure 3 3
Multiple Organ Failure 3 3
Thromboembolism 3 3
Arrhythmia 3 3
Cardiogenic Shock 3 3
Myocardial Infarction 2 2
Unspecified Respiratory Problem 2 2
Swelling/ Edema 2 2
Ventricular Fibrillation 2 2
Bacterial Infection 2 2
Cardiac Tamponade 2 2
Autoimmune Disorder 2 2
Asthma 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. I Feb-03-2022
2 Maquet Cardiovascular Us Sales, Llc II Dec-17-2020
3 Maquet Medical Systems USA II Feb-13-2024
4 Maquet Medical Systems USA II May-30-2023
5 Maquet Medical Systems USA II May-26-2023
6 Maquet Medical Systems USA II Feb-28-2023
7 Maquet Medical Systems USA II Sep-19-2022
8 Medtronic Perfusion Systems II Nov-10-2025
9 Medtronic Perfusion Systems II Jan-27-2023
10 Medtronic Perfusion Systems II Jul-04-2020
11 Terumo Cardiovascular Systems Corporation II Apr-05-2023
12 Terumo Cardiovascular Systems Corporation II Dec-14-2020
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