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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
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 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 489 489
2020 442 442
2021 595 595
2022 559 559
2023 741 741
2024 351 351

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 500 500
Leak/Splash 360 360
Break 202 202
Infusion or Flow Problem 167 167
Increase in Pressure 160 160
Material Separation 152 152
Packaging Problem 116 116
Pressure Problem 109 109
Use of Device Problem 107 107
Obstruction of Flow 87 87
Crack 84 84
Gas Output Problem 78 78
Coagulation in Device or Device Ingredient 65 65
Defective Component 58 58
Material Deformation 58 58
Unable to Obtain Readings 57 57
Detachment of Device or Device Component 56 56
Adverse Event Without Identified Device or Use Problem 47 47
Air/Gas in Device 44 44
Insufficient Information 42 42
Manufacturing, Packaging or Shipping Problem 40 40
Contamination 34 34
Shipping Damage or Problem 34 34
Insufficient Flow or Under Infusion 33 33
Improper Flow or Infusion 30 30
Material Puncture/Hole 30 30
Device Sensing Problem 29 29
Unexpected Therapeutic Results 29 29
Mechanical Problem 26 26
No Flow 26 26
Noise, Audible 26 26
Decrease in Pressure 25 25
Gas/Air Leak 24 24
Improper Chemical Reaction 24 24
Disconnection 24 24
Failure to Deliver 23 23
Defective Device 22 22
Fracture 20 20
Connection Problem 20 20
Device Difficult to Setup or Prepare 18 18
Inaccurate Delivery 17 17
Loose or Intermittent Connection 17 17
Contamination /Decontamination Problem 17 17
Particulates 16 16
Medical Gas Supply Problem 16 16
Output Problem 16 16
Device Damaged Prior to Use 16 16
Scratched Material 12 12
Low Readings 12 12
Pumping Stopped 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1953 1953
No Patient Involvement 321 321
No Consequences Or Impact To Patient 320 320
No Known Impact Or Consequence To Patient 174 174
Hemorrhage/Bleeding 103 103
Insufficient Information 91 91
Blood Loss 60 60
No Information 50 50
Low Oxygen Saturation 39 39
Death 38 38
Cardiac Arrest 23 23
Hypoxia 22 22
Injury 16 16
Low Blood Pressure/ Hypotension 15 15
Hemolysis 11 11
Sepsis 11 11
Air Embolism 10 10
Unspecified Infection 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Stroke/CVA 6 6
Thrombosis/Thrombus 6 6
Ischemia Stroke 5 5
Abnormal Blood Gases 5 5
Bradycardia 5 5
Anemia 5 5
Coagulation Disorder 4 4
Respiratory Failure 3 3
Thromboembolism 3 3
Thrombocytopenia 3 3
Ischemia 3 3
Lactate Dehydrogenase Increased 3 3
Hypothermia 3 3
Hypovolemia 2 2
Thrombus 2 2
Swelling/ Edema 2 2
Asystole 2 2
Septic Shock 2 2
Aortic Dissection 2 2
Arrhythmia 2 2
Neurological Deficit/Dysfunction 2 2
Autoimmune Disorder 2 2
Infarction, Cerebral 2 2
Lupus 2 2
Inflammation 2 2
Hematoma 2 2
Exsanguination 2 2
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Pulmonary Dysfunction 1 1
Respiratory Insufficiency 1 1

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 Jan-27-2023
11 Medtronic Perfusion Systems II Jul-04-2020
12 Terumo Cardiovascular Systems Corporation II Apr-05-2023
13 Terumo Cardiovascular Systems Corporation II Dec-14-2020
14 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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