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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 2
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
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 739 739
2024 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 431 431
Leak/Splash 343 343
Break 197 197
Infusion or Flow Problem 161 161
Increase in Pressure 151 151
Material Separation 145 145
Packaging Problem 114 114
Pressure Problem 107 107
Use of Device Problem 97 97
Obstruction of Flow 81 81
Crack 77 77
Coagulation in Device or Device Ingredient 65 65
Gas Output Problem 58 58
Unable to Obtain Readings 57 57
Detachment of Device or Device Component 56 56
Defective Component 55 55
Material Deformation 52 52
Adverse Event Without Identified Device or Use Problem 42 42
Manufacturing, Packaging or Shipping Problem 40 40
Insufficient Information 38 38
Shipping Damage or Problem 34 34
Insufficient Flow or Under Infusion 33 33
Contamination 33 33
Air/Gas in Device 30 30
Improper Flow or Infusion 29 29
Device Sensing Problem 29 29
No Flow 26 26
Unexpected Therapeutic Results 25 25
Material Puncture/Hole 25 25
Mechanical Problem 24 24
Failure to Deliver 23 23
Improper Chemical Reaction 23 23
Defective Device 22 22
Noise, Audible 22 22
Decrease in Pressure 22 22
Disconnection 21 21
Gas/Air Leak 19 19
Connection Problem 18 18
Contamination /Decontamination Problem 17 17
Fracture 17 17
Inaccurate Delivery 17 17
Device Damaged Prior to Use 16 16
Device Difficult to Setup or Prepare 16 16
Loose or Intermittent Connection 16 16
Particulates 16 16
Output Problem 16 16
Medical Gas Supply Problem 15 15
Scratched Material 12 12
Partial Blockage 12 12
Component Missing 12 12
Pumping Stopped 11 11
Restricted Flow rate 11 11
Dent in Material 11 11
Gradient Increase 10 10
Tear, Rip or Hole in Device Packaging 9 9
Low Readings 9 9
Blocked Connection 9 9
Device Contamination with Chemical or Other Material 9 9
Temperature Problem 9 9
Complete Blockage 8 8
Failure to Sense 7 7
Filtration Problem 7 7
Material Integrity Problem 7 7
Device Markings/Labelling Problem 6 6
High Readings 6 6
Loss of or Failure to Bond 6 6
Device Alarm System 5 5
Fitting Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Appropriate Term/Code Not Available 5 5
Material Split, Cut or Torn 5 5
Misassembled During Installation 4 4
Patient Device Interaction Problem 4 4
Unintended Movement 4 4
Pumping Problem 4 4
Battery Problem 4 4
Material Twisted/Bent 4 4
Device Contaminated During Manufacture or Shipping 4 4
Failure to Prime 4 4
Microbial Contamination of Device 4 4
Clumping in Device or Device Ingredient 4 4
Material Discolored 4 4
Delivered as Unsterile Product 3 3
Backflow 3 3
Decoupling 3 3
Incomplete or Missing Packaging 3 3
Material Rupture 3 3
Therapeutic or Diagnostic Output Failure 3 3
Suction Failure 3 3
Priming Problem 2 2
Missing Information 2 2
Output below Specifications 2 2
Power Problem 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Device Dislodged or Dislocated 2 2
Free or Unrestricted Flow 2 2
Deformation Due to Compressive Stress 2 2
Device Ingredient or Reagent Problem 2 2
No Device Output 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1756 1756
No Patient Involvement 321 321
No Consequences Or Impact To Patient 320 320
No Known Impact Or Consequence To Patient 174 174
Hemorrhage/Bleeding 89 89
Insufficient Information 86 86
Blood Loss 60 60
No Information 50 50
Death 38 38
Low Oxygen Saturation 37 37
Cardiac Arrest 23 23
Hypoxia 21 21
Injury 16 16
Low Blood Pressure/ Hypotension 14 14
Hemolysis 11 11
Air Embolism 9 9
Sepsis 9 9
Unspecified Infection 6 6
Thrombosis/Thrombus 6 6
Stroke/CVA 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Abnormal Blood Gases 5 5
Anemia 5 5
Bradycardia 5 5
Coagulation Disorder 4 4
Hypothermia 3 3
Ischemia 3 3
Ischemia Stroke 3 3
Thrombocytopenia 3 3
Thromboembolism 3 3
Respiratory Failure 3 3
Hypovolemia 2 2
Inflammation 2 2
Thrombus 2 2
Septic Shock 2 2
Aortic Dissection 2 2
Lactate Dehydrogenase Increased 2 2
Swelling/ Edema 2 2
Asystole 2 2
Lupus 2 2
Neurological Deficit/Dysfunction 2 2
Exsanguination 2 2
Hematoma 2 2
Autoimmune Disorder 2 2
Infarction, Cerebral 2 2
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Edema 1 1
Embolism 1 1
Exposure to Body Fluids 1 1
Anoxia 1 1
Adult Respiratory Distress Syndrome 1 1
Anaphylactic Shock 1 1
Hypoventilation 1 1
Hypersensitivity/Allergic reaction 1 1
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Pulmonary Edema 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Seizures 1 1
Cardiovascular Insufficiency 1 1
Cough 1 1
Respiratory Insufficiency 1 1
Muscle/Tendon Damage 1 1
Low Cardiac Output 1 1
Hematuria 1 1
Diminished Pulse Pressure 1 1
Multiple Organ Failure 1 1
Shock 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Transient Ischemic Attack 1 1
Jaundice 1 1
Cardiogenic Shock 1 1
Anxiety 1 1
Heart Failure 1 1
Brain Injury 1 1
Increased Respiratory Rate 1 1
Loss of consciousness 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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