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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 3
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 321 321
2019 489 489
2020 442 442
2021 595 595
2022 559 559
2023 741 741
2024 441 441

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 558 558
Leak/Splash 426 426
Break 230 230
Infusion or Flow Problem 189 189
Increase in Pressure 180 180
Material Separation 152 152
Use of Device Problem 128 128
Pressure Problem 126 126
Packaging Problem 117 117
Crack 106 106
Obstruction of Flow 93 93
Gas Output Problem 87 87
Coagulation in Device or Device Ingredient 75 75
Material Deformation 71 71
Defective Component 63 63
Detachment of Device or Device Component 58 58
Unable to Obtain Readings 57 57
Adverse Event Without Identified Device or Use Problem 55 55
Air/Gas in Device 53 53
Insufficient Information 45 45
Manufacturing, Packaging or Shipping Problem 44 44
Insufficient Flow or Under Infusion 37 37
Improper Flow or Infusion 35 35
Fracture 34 34
Shipping Damage or Problem 34 34
Contamination 34 34
Material Puncture/Hole 31 31
Unexpected Therapeutic Results 30 30
Device Sensing Problem 29 29
Decrease in Pressure 29 29
Gas/Air Leak 29 29
Mechanical Problem 28 28
Noise, Audible 27 27
Disconnection 26 26
No Flow 26 26
Connection Problem 26 26
Failure to Deliver 26 26
Improper Chemical Reaction 25 25
Defective Device 23 23
Device Damaged Prior to Use 20 20
Device Difficult to Setup or Prepare 19 19
Component Missing 19 19
Particulates 19 19
Loose or Intermittent Connection 18 18
Contamination /Decontamination Problem 17 17
Medical Gas Supply Problem 17 17
Inaccurate Delivery 17 17
Output Problem 17 17
Device Operates Differently Than Expected 16 16
Low Readings 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2026 2026
No Consequences Or Impact To Patient 412 412
No Patient Involvement 410 410
No Known Impact Or Consequence To Patient 251 251
Hemorrhage/Bleeding 114 114
Insufficient Information 95 95
Blood Loss 90 90
No Information 60 60
Death 48 49
Low Oxygen Saturation 45 45
Cardiac Arrest 25 25
Hypoxia 23 23
Injury 21 21
Low Blood Pressure/ Hypotension 15 15
Air Embolism 13 13
Sepsis 12 12
Hemolysis 11 11
Unspecified Infection 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Stroke/CVA 6 6
Abnormal Blood Gases 6 6
Anemia 6 6
Thrombosis/Thrombus 6 6
Ischemia Stroke 5 5
Thrombus 5 5
Bradycardia 5 5
Thrombocytopenia 4 4
Coagulation Disorder 4 4
Respiratory Failure 3 3
Thromboembolism 3 3
Lactate Dehydrogenase Increased 3 3
Inflammation 3 3
Ischemia 3 3
Hypothermia 3 3
Hypovolemia 2 2
Bacterial Infection 2 3
Swelling/ Edema 2 2
Asystole 2 2
Septic Shock 2 2
Aortic Dissection 2 2
Neurological Deficit/Dysfunction 2 2
Patient Problem/Medical Problem 2 2
Autoimmune Disorder 2 2
Arrhythmia 2 2
Infarction, Cerebral 2 2
Lupus 2 2
Hematoma 2 2
Exsanguination 2 2
Hematuria 2 2
Hypersensitivity/Allergic reaction 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 LivaNova USA II May-23-2018
4 Maquet Cardiovascular Us Sales, Llc II Dec-17-2020
5 Maquet Cardiovascular Us Sales, Llc II Sep-13-2019
6 Maquet Cardiovascular Us Sales, Llc I Nov-28-2018
7 Maquet Medical Systems USA II Feb-13-2024
8 Maquet Medical Systems USA II May-30-2023
9 Maquet Medical Systems USA II May-26-2023
10 Maquet Medical Systems USA II Feb-28-2023
11 Maquet Medical Systems USA II Sep-19-2022
12 Medtronic Perfusion Systems II Jan-27-2023
13 Medtronic Perfusion Systems II Jul-04-2020
14 Terumo Cardiovascular Systems Corporation II Apr-05-2023
15 Terumo Cardiovascular Systems Corporation II Dec-14-2020
16 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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