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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 493 493

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1157 1157
Leak/Splash 343 343
Increase in Pressure 331 331
Gas Output Problem 258 258
Break 186 186
Infusion or Flow Problem 171 171
Obstruction of Flow 167 168
Material Separation 162 162
Pressure Problem 144 145
Packaging Problem 129 129
Use of Device Problem 124 124
Crack 119 119
Air/Gas in Device 119 119
Material Deformation 97 97
Delivered as Unsterile Product 66 66
Adverse Event Without Identified Device or Use Problem 64 64
Noise, Audible 63 63
Mechanical Problem 58 58
Coagulation in Device or Device Ingredient 58 58
Insufficient Information 54 54
Material Puncture/Hole 51 51
Unexpected Therapeutic Results 47 47
Failure to Deliver 45 45
Defective Component 44 44
Detachment of Device or Device Component 42 42
Gas/Air Leak 38 39
Contamination 38 38
Improper Chemical Reaction 34 34
Manufacturing, Packaging or Shipping Problem 34 34
Shipping Damage or Problem 32 32
Decrease in Pressure 31 32
Insufficient Flow or Under Infusion 30 30
Improper Flow or Infusion 29 29
Contamination /Decontamination Problem 25 25
Partial Blockage 23 23
Disconnection 23 23
Connection Problem 22 22
Medical Gas Supply Problem 20 20
Fracture 20 20
No Flow 19 19
Device Sensing Problem 19 19
Defective Device 16 16
Output Problem 16 16
Temperature Problem 15 15
Loose or Intermittent Connection 14 14
Low Readings 14 14
Pumping Stopped 13 13
Particulates 13 13
Unable to Obtain Readings 12 12
Scratched Material 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3394 3398
Hemorrhage/Bleeding 274 274
No Patient Involvement 176 176
No Consequences Or Impact To Patient 173 173
Insufficient Information 159 160
No Known Impact Or Consequence To Patient 61 61
Low Oxygen Saturation 56 56
Cardiac Arrest 34 34
Hypoxia 33 33
Death 26 26
Blood Loss 25 25
Low Blood Pressure/ Hypotension 23 23
Sepsis 17 17
No Information 17 17
Thrombosis/Thrombus 16 16
Hemolysis 16 16
Air Embolism 12 12
Coagulation Disorder 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Anemia 9 9
Abnormal Blood Gases 8 8
Stroke/CVA 8 8
Unspecified Infection 8 8
Injury 7 7
Respiratory Failure 5 5
Ischemia 5 5
Ischemia Stroke 5 5
Pneumonia 5 5
Bradycardia 4 4
Thrombocytopenia 4 4
Brain Injury 4 4
Asystole 4 4
Tachycardia 4 4
Septic Shock 4 4
Lactate Dehydrogenase Increased 3 3
Hypothermia 3 3
Multiple Organ Failure 3 3
Renal Failure 3 3
Thromboembolism 3 3
Cardiogenic Shock 3 3
Arrhythmia 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
Inflammation 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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