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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 2
EUROSETS S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 3
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
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 561 561
2023 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 339 339
Fluid/Blood Leak 232 232
Break 176 176
Infusion or Flow Problem 153 153
Increase in Pressure 132 132
Packaging Problem 115 115
Material Separation 103 103
Pressure Problem 94 94
Use of Device Problem 92 92
Coagulation in Device or Device Ingredient 72 72
Crack 61 61
Obstruction of Flow 59 59
Detachment of Device or Device Component 57 57
Unable to Obtain Readings 54 54
Defective Component 48 48
Manufacturing, Packaging or Shipping Problem 39 39
Gas Output Problem 38 38
Insufficient Flow or Under Infusion 34 34
Improper Flow or Infusion 32 32
Adverse Event Without Identified Device or Use Problem 32 32
Material Deformation 30 30
Fracture 30 30
Device Sensing Problem 26 26
Failure to Deliver 24 24
No Flow 24 24
Insufficient Information 23 23
Defective Device 23 23
Contamination 22 22
Connection Problem 20 20
Device Damaged Prior to Use 18 18
Component Missing 18 18
Air/Gas in Device 18 18
Decrease in Pressure 17 17
Disconnection 17 17
Improper Chemical Reaction 17 17
Noise, Audible 16 16
Device Operates Differently Than Expected 16 16
Contamination /Decontamination Problem 16 16
Inaccurate Delivery 16 16
Mechanical Problem 16 16
Device Difficult to Setup or Prepare 16 16
Output Problem 15 15
Medical Gas Supply Problem 14 14
Loose or Intermittent Connection 14 14
Gas/Air Leak 13 13
Tear, Rip or Hole in Device Packaging 12 12
Shipping Damage or Problem 12 12
Unexpected Therapeutic Results 11 11
Particulates 10 10
Restricted Flow rate 10 10
Complete Blockage 10 10
Device Contamination with Chemical or Other Material 10 10
Scratched Material 10 10
Device Operational Issue 9 9
Dent in Material 9 9
Partial Blockage 9 9
Pumping Stopped 9 9
Blocked Connection 8 8
Low Readings 8 8
Filtration Problem 7 7
Material Integrity Problem 7 7
Failure to Sense 7 7
Gradient Increase 6 6
Detachment Of Device Component 5 5
Temperature Problem 5 5
Device Contaminated During Manufacture or Shipping 4 4
Device Markings/Labelling Problem 4 4
Insufficient Heating 4 4
Loss of or Failure to Bond 4 4
Clumping in Device or Device Ingredient 4 4
Material Puncture/Hole 4 4
Failure to Prime 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Material Split, Cut or Torn 4 4
Misassembled During Installation 4 4
No Device Output 3 3
Incomplete or Missing Packaging 3 3
Microbial Contamination of Device 3 3
Material Discolored 3 3
Free or Unrestricted Flow 3 3
Output below Specifications 3 3
Incorrect Device Or Component Shipped 3 3
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Suction Failure 3 3
Patient Device Interaction Problem 2 2
Misassembly by Users 2 2
Pumping Problem 2 2
Power Problem 2 2
Device Dislodged or Dislocated 2 2
Device Ingredient or Reagent Problem 2 2
High Readings 2 2
Failure to Calibrate 2 2
Device Alarm System 2 2
Backflow 2 2
Inaccurate Flow Rate 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Fragmentation 2 2
Incorrect Measurement 2 2
Fitting Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1093 1093
No Consequences Or Impact To Patient 412 412
No Patient Involvement 410 410
No Known Impact Or Consequence To Patient 251 251
Blood Loss 90 90
No Information 60 60
Hemorrhage/Bleeding 54 54
Insufficient Information 51 51
Death 48 49
Low Oxygen Saturation 27 27
Injury 21 21
Cardiac Arrest 19 19
Hypoxia 15 15
Low Blood Pressure/ Hypotension 11 11
Air Embolism 10 10
Hemolysis 10 10
Unspecified Infection 7 7
Sepsis 6 6
Thrombus 5 5
Abnormal Blood Gases 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Thrombosis/Thrombus 4 4
Thromboembolism 3 3
Respiratory Failure 3 3
Anemia 3 3
Inflammation 3 3
Ischemia 3 3
Hypothermia 3 3
Bradycardia 3 3
Thrombocytopenia 3 3
Lactate Dehydrogenase Increased 2 2
Patient Problem/Medical Problem 2 2
Ischemia Stroke 2 2
Exsanguination 2 2
Lupus 2 2
Neurological Deficit/Dysfunction 2 2
Autoimmune Disorder 2 2
Stroke/CVA 2 2
Infarction, Cerebral 2 2
Hypovolemia 2 2
Septic Shock 2 2
Hematuria 2 2
Aortic Dissection 2 2
Iatrogenic Source 1 2
Low Cardiac Output 1 1
Alteration In Body Temperature 1 1
Diminished Pulse Pressure 1 1
Cardiovascular Insufficiency 1 1
Respiratory Insufficiency 1 1
Muscle/Tendon Damage 1 1
No Code Available 1 1
Not Applicable 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Transient Ischemic Attack 1 1
Jaundice 1 1
Heart Failure 1 1
Brain Injury 1 1
Anxiety 1 1
Laceration(s) of Esophagus 1 2
Loss of consciousness 1 1
Increased Respiratory Rate 1 1
Respiratory Acidosis 1 1
Coagulation Disorder 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Edema 1 1
Embolism 1 1
Bacterial Infection 1 2
Anoxia 1 1
Adult Respiratory Distress Syndrome 1 1
Anaphylactic Shock 1 1
Respiratory Distress 1 1
Seizures 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 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-28-2023
8 Maquet Medical Systems USA II Sep-19-2022
9 Medtronic Perfusion Systems II Jan-27-2023
10 Medtronic Perfusion Systems II Jul-04-2020
11 Terumo Cardiovascular Systems Corporation II Dec-14-2020
12 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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