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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 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
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
2017 388 388
2018 321 321
2019 489 489
2020 442 442
2021 595 595
2022 559 559
2023 739 739
2024 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 491 491
Leak/Splash 479 479
Break 267 267
Infusion or Flow Problem 188 188
Increase in Pressure 182 182
Pressure Problem 147 147
Material Separation 145 145
Use of Device Problem 122 122
Packaging Problem 118 118
Crack 116 116
Obstruction of Flow 86 86
Coagulation in Device or Device Ingredient 76 76
Material Deformation 64 64
Gas Output Problem 63 63
Defective Component 62 62
Detachment of Device or Device Component 58 58
Unable to Obtain Readings 57 57
Adverse Event Without Identified Device or Use Problem 53 53
Device Operates Differently Than Expected 52 52
Manufacturing, Packaging or Shipping Problem 44 44
Insufficient Information 42 42
Insufficient Flow or Under Infusion 41 41
Improper Flow or Infusion 38 38
Shipping Damage or Problem 37 37
Connection Problem 35 35
Contamination 33 33
Fracture 31 31
Disconnection 30 30
Air/Gas in Device 30 30
Device Sensing Problem 29 29
Device Damaged Prior to Use 29 29
No Flow 28 28
Decrease in Pressure 27 27
Material Puncture/Hole 25 25
Mechanical Problem 25 25
Unexpected Therapeutic Results 25 25
Medical Gas Supply Problem 25 25
Failure to Deliver 24 24
Defective Device 24 24
Gas/Air Leak 23 23
Improper Chemical Reaction 23 23
Noise, Audible 23 23
Component Missing 21 21
Complete Blockage 20 20
Particulates 19 19
Low Readings 19 19
Device Operational Issue 19 19
Loose or Intermittent Connection 18 18
Contamination /Decontamination Problem 17 17
Inaccurate Delivery 17 17
Filtration Problem 17 17
Output Problem 17 17
Device Difficult to Setup or Prepare 16 16
Partial Blockage 14 14
Device Contamination with Chemical or Other Material 13 13
Tear, Rip or Hole in Device Packaging 13 13
Scratched Material 12 12
Temperature Problem 12 12
Dent in Material 11 11
Restricted Flow rate 11 11
Pumping Stopped 11 11
Detachment Of Device Component 10 10
Gradient Increase 10 10
Blocked Connection 10 10
Material Integrity Problem 8 8
Air Leak 8 8
Failure to Sense 7 7
Fitting Problem 6 6
Failure to Prime 6 6
Loss of or Failure to Bond 6 6
High Readings 6 6
Device Markings/Labelling Problem 6 6
Out-Of-Box Failure 5 5
Appropriate Term/Code Not Available 5 5
Pumping Problem 5 5
Device Alarm System 5 5
Insufficient Heating 5 5
Material Discolored 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Material Split, Cut or Torn 5 5
Patient Device Interaction Problem 4 4
Misassembled During Installation 4 4
Device Inoperable 4 4
Misassembled 4 4
Clumping in Device or Device Ingredient 4 4
Decoupling 4 4
Unintended Movement 4 4
Material Twisted/Bent 4 4
Device Contaminated During Manufacture or Shipping 4 4
Incorrect Device Or Component Shipped 4 4
Microbial Contamination of Device 4 4
Device Issue 4 4
Battery Problem 4 4
Incomplete or Missing Packaging 3 3
Free or Unrestricted Flow 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output below Specifications 3 3
Backflow 3 3
Delivered as Unsterile Product 3 3
No Device Output 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1756 1756
No Patient Involvement 551 551
No Consequences Or Impact To Patient 490 490
No Known Impact Or Consequence To Patient 338 338
Blood Loss 137 137
Hemorrhage/Bleeding 97 97
Insufficient Information 86 86
No Information 74 74
Death 59 60
Low Oxygen Saturation 48 48
Injury 27 27
Cardiac Arrest 24 24
Hypoxia 21 21
Low Blood Pressure/ Hypotension 16 16
Hemolysis 11 11
Air Embolism 11 11
Sepsis 10 10
Abnormal Blood Gases 7 7
Unspecified Infection 7 7
Stroke/CVA 6 6
Thrombus 6 6
Thrombosis/Thrombus 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Code Available 5 5
Bradycardia 5 5
Anemia 5 5
Coagulation Disorder 5 5
Infarction, Cerebral 4 4
Inflammation 3 3
Ischemia 3 3
Hypothermia 3 3
Respiratory Failure 3 3
Thromboembolism 3 3
Patient Problem/Medical Problem 3 3
Ischemia Stroke 3 3
Thrombocytopenia 3 3
Lactate Dehydrogenase Increased 2 2
Swelling/ Edema 2 2
Asystole 2 2
Hematuria 2 2
Alteration In Body Temperature 2 2
Aortic Dissection 2 2
Heart Failure 2 2
Hypovolemia 2 2
Pulmonary Edema 2 2
Septic Shock 2 2
Lupus 2 2
Neurological Deficit/Dysfunction 2 2
Exsanguination 2 2
Hematoma 2 2
Autoimmune Disorder 2 2
Bacterial Infection 1 2
Exposure to Body Fluids 1 1
Anoxia 1 1
Adult Respiratory Distress Syndrome 1 1
Anaphylactic Shock 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Edema 1 1
Embolism 1 1
Embolus 1 1
Cardiac Enzyme Elevation 1 1
Congestive Heart Failure 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 1 1
Paralysis 1 1
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Shock 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Jaundice 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Seizures 1 1
Hypoventilation 1 1
Cardiogenic Shock 1 1
Anxiety 1 1
Brain Injury 1 1
Disability 1 1
Laceration(s) of Esophagus 1 2
Loss of consciousness 1 1
Iatrogenic Source 1 2
Low Cardiac Output 1 1
Diminished Pulse Pressure 1 1
Increased Respiratory Rate 1 1
Respiratory Acidosis 1 1
Multiple Organ Failure 1 1
Not Applicable 1 1
Cardiovascular Insufficiency 1 1
Cough 1 1
Respiratory Insufficiency 1 1
Muscle/Tendon Damage 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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