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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 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 2
  1.  K201916  Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hol ...
  2.  K211495  EOS PMP
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 442 442
2021 595 595
2022 559 559
2023 740 740
2024 536 536
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 557 557
Leak/Splash 292 292
Break 177 177
Material Separation 153 153
Increase in Pressure 153 153
Infusion or Flow Problem 142 142
Packaging Problem 118 118
Gas Output Problem 93 93
Use of Device Problem 90 90
Pressure Problem 89 89
Crack 88 88
Obstruction of Flow 87 87
Material Deformation 63 63
Air/Gas in Device 60 60
Coagulation in Device or Device Ingredient 53 53
Adverse Event Without Identified Device or Use Problem 46 46
Defective Component 42 42
Insufficient Information 42 42
Detachment of Device or Device Component 39 39
Contamination 34 34
Unexpected Therapeutic Results 33 33
Mechanical Problem 32 32
Material Puncture/Hole 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Noise, Audible 29 29
Insufficient Flow or Under Infusion 29 29
Shipping Damage or Problem 28 28
Improper Chemical Reaction 28 28
Failure to Deliver 28 28
Decrease in Pressure 27 27
Gas/Air Leak 26 26
Improper Flow or Infusion 24 24
Disconnection 22 22
Connection Problem 20 20
Contamination /Decontamination Problem 20 20
Device Sensing Problem 19 19
No Flow 19 19
Output Problem 15 15
Fracture 14 14
Medical Gas Supply Problem 14 14
Particulates 13 13
Low Readings 13 13
Scratched Material 12 12
Temperature Problem 12 12
Unable to Obtain Readings 12 12
Pumping Stopped 12 12
Loose or Intermittent Connection 12 12
Defective Device 12 12
Dent in Material 11 11
High Readings 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2149 2149
No Patient Involvement 176 176
No Consequences Or Impact To Patient 173 173
Hemorrhage/Bleeding 120 120
Insufficient Information 102 102
No Known Impact Or Consequence To Patient 61 61
Low Oxygen Saturation 46 46
Death 26 26
Blood Loss 25 25
Hypoxia 24 24
Cardiac Arrest 23 23
No Information 17 17
Low Blood Pressure/ Hypotension 14 14
Sepsis 13 13
Air Embolism 11 11
Hemolysis 10 10
Thrombosis/Thrombus 10 10
Injury 7 7
Stroke/CVA 6 6
Anemia 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unspecified Infection 6 6
Abnormal Blood Gases 5 5
Ischemia Stroke 5 5
Thrombocytopenia 4 4
Coagulation Disorder 4 4
Bradycardia 4 4
Respiratory Failure 4 4
Hypothermia 3 3
Thromboembolism 3 3
Lactate Dehydrogenase Increased 3 3
Multiple Organ Failure 3 3
Ischemia 3 3
Arrhythmia 2 2
Lupus 2 2
Autoimmune Disorder 2 2
Brain Injury 2 2
Exsanguination 2 2
Asystole 2 2
Hematoma 2 2
Swelling/ Edema 2 2
Hypovolemia 2 2
Inflammation 2 2
Septic Shock 2 2
Pneumonia 1 1
Respiratory Insufficiency 1 1
Cardiopulmonary Arrest 1 1
Loss of consciousness 1 1
Seizures 1 1
Cardiovascular Insufficiency 1 1

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 Jan-27-2023
9 Medtronic Perfusion Systems II Jul-04-2020
10 Terumo Cardiovascular Systems Corporation II Apr-05-2023
11 Terumo Cardiovascular Systems Corporation II Dec-14-2020
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