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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 SRL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
QURA S.R.L
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 489 489
2020 442 443
2021 595 595
2022 559 560
2023 738 739
2024 535 536
2025 987 987
2026 260 260

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1074 1074
Leak/Splash 417 417
Increase in Pressure 335 335
Gas Output Problem 236 236
Break 218 218
Infusion or Flow Problem 201 201
Pressure Problem 160 161
Material Separation 160 160
Obstruction of Flow 159 160
Use of Device Problem 146 146
Packaging Problem 128 128
Crack 121 121
Air/Gas in Device 108 108
Material Deformation 98 98
Coagulation in Device or Device Ingredient 71 71
Adverse Event Without Identified Device or Use Problem 66 66
Delivered as Unsterile Product 61 61
Defective Component 60 60
Detachment of Device or Device Component 58 58
Unable to Obtain Readings 57 57
Noise, Audible 55 55
Mechanical Problem 55 55
Insufficient Information 55 55
Unexpected Therapeutic Results 46 46
Material Puncture/Hole 44 44
Manufacturing, Packaging or Shipping Problem 43 43
Failure to Deliver 42 42
Shipping Damage or Problem 38 38
Contamination 37 37
Insufficient Flow or Under Infusion 35 35
Improper Flow or Infusion 34 34
Gas/Air Leak 34 35
Improper Chemical Reaction 33 33
Decrease in Pressure 31 32
Device Sensing Problem 29 29
Contamination /Decontamination Problem 27 27
Fracture 27 27
Partial Blockage 27 27
Defective Device 26 26
No Flow 26 26
Disconnection 25 25
Connection Problem 21 21
Medical Gas Supply Problem 20 20
Loose or Intermittent Connection 19 19
Device Difficult to Setup or Prepare 19 19
Inaccurate Delivery 17 17
Output Problem 17 17
Particulates 16 16
Device Damaged Prior to Use 16 16
Temperature Problem 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3196 3200
No Patient Involvement 321 321
No Consequences Or Impact To Patient 320 320
Hemorrhage/Bleeding 246 246
No Known Impact Or Consequence To Patient 174 174
Insufficient Information 152 153
Blood Loss 60 60
Low Oxygen Saturation 56 56
No Information 50 50
Death 38 38
Cardiac Arrest 33 33
Hypoxia 29 29
Low Blood Pressure/ Hypotension 23 23
Hemolysis 17 17
Sepsis 17 17
Injury 16 16
Thrombosis/Thrombus 14 14
Air Embolism 13 13
Anemia 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Coagulation Disorder 7 7
Stroke/CVA 7 7
Unspecified Infection 7 7
Abnormal Blood Gases 6 6
Respiratory Failure 5 5
Ischemia Stroke 5 5
Pneumonia 5 5
Bradycardia 5 5
Brain Injury 4 4
Thrombocytopenia 4 4
Ischemia 4 4
Tachycardia 4 4
Asystole 4 4
Septic Shock 4 4
Thromboembolism 3 3
Arrhythmia 3 3
Renal Failure 3 3
Multiple Organ Failure 3 3
Hypothermia 3 3
Lactate Dehydrogenase Increased 3 3
Cardiogenic Shock 3 3
Bacterial Infection 2 2
Thrombus 2 2
Myocardial Infarction 2 2
Swelling/ Edema 2 2
Ventilator Dependent 2 2
Hypovolemia 2 2
Ventricular Fibrillation 2 2
Cardiac Tamponade 2 2
Infarction, Cerebral 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. I Feb-03-2022
2 GETINGE US SALES LLC II Dec-12-2019
3 Maquet Cardiovascular Us Sales, Llc II Dec-17-2020
4 Maquet Cardiovascular Us Sales, Llc II Sep-13-2019
5 Maquet Medical Systems USA II Feb-13-2024
6 Maquet Medical Systems USA II May-30-2023
7 Maquet Medical Systems USA II May-26-2023
8 Maquet Medical Systems USA II Feb-28-2023
9 Maquet Medical Systems USA II Sep-19-2022
10 Medtronic Perfusion Systems II Nov-10-2025
11 Medtronic Perfusion Systems II Jan-27-2023
12 Medtronic Perfusion Systems II Jul-04-2020
13 Terumo Cardiovascular Systems Corporation II Apr-05-2023
14 Terumo Cardiovascular Systems Corporation II Dec-14-2020
15 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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