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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
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHALICE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
EUROSETS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
2016 442 442
2017 388 388
2018 321 321
2019 489 489
2020 442 442
2021 503 503

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 429 429
Break 198 198
Fluid Leak 196 196
Pressure Problem 139 139
Increase in Pressure 138 138
Infusion or Flow Problem 117 117
Use of Device Problem 90 90
Packaging Problem 85 85
Device Operates Differently Than Expected 75 75
Coagulation in Device or Device Ingredient 75 75
Crack 73 73
Unable to Obtain Readings 55 55
Detachment of Device or Device Component 55 55
Defective Component 51 51
Fracture 43 43
Improper Flow or Infusion 40 40
Device Contamination with Chemical or Other Material 35 35
Connection Problem 35 35
Insufficient Flow or Under Infusion 34 34
Device Damaged Prior to Use 33 33
Adverse Event Without Identified Device or Use Problem 33 33
Obstruction of Flow 29 29
Air Leak 28 28
Material Deformation 27 27
No Flow 25 25
Disconnection 25 25
Manufacturing, Packaging or Shipping Problem 23 23
Device Operational Issue 23 23
Component Missing 22 22
Defective Device 22 22
Failure to Deliver 21 21
Insufficient Information 21 21
Medical Gas Supply Problem 20 20
Gas Output Problem 19 19
Complete Blockage 19 19
Mechanical Problem 17 17
Filtration Problem 17 17
Detachment Of Device Component 16 16
Decrease in Pressure 15 15
Tear, Rip or Hole in Device Packaging 15 15
Temperature Problem 14 14
Device Difficult to Setup or Prepare 14 14
Loose or Intermittent Connection 14 14
Device Sensing Problem 13 13
Contamination /Decontamination Problem 13 13
Low Readings 12 12
Inaccurate Delivery 12 12
Material Separation 12 12
Shipping Damage or Problem 12 12
Device Issue 11 11
Improper Chemical Reaction 11 11
Noise, Audible 11 11
Gas Leak 10 10
Restricted Flow rate 10 10
Contamination 9 9
Partial Blockage 9 9
Occlusion Within Device 9 9
Output Problem 9 9
Air/Gas in Device 7 7
Material Integrity Problem 7 7
Incorrect Device Or Component Shipped 7 7
Device Displays Incorrect Message 7 7
Particulates 7 7
Failure to Prime 6 6
Out-Of-Box Failure 6 6
Device Inoperable 5 5
Improper or Incorrect Procedure or Method 5 5
Insufficient Heating 5 5
Material Discolored 5 5
Device Alarm System 4 4
Circuit Failure 4 4
Failure to Sense 4 4
Misassembled 4 4
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Appropriate Term/Code Not Available 3 3
Pumping Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Free or Unrestricted Flow 3 3
Improper Device Output 3 3
Kinked 3 3
No Device Output 3 3
Fitting Problem 3 3
Loss of or Failure to Bond 3 3
No Display/Image 3 3
Gradient Increase 3 3
Inaccurate Flow Rate 2 2
False Reading From Device Non-Compliance 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Melted 2 2
Excess Flow or Over-Infusion 2 2
Labelling, Instructions for Use or Training Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Blocked Connection 2 2
Device Dislodged or Dislocated 2 2
Failure to Calibrate 2 2
Patient-Device Incompatibility 2 2
Output below Specifications 2 2
Material Split, Cut or Torn 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 667 667
No Consequences Or Impact To Patient 588 588
No Known Impact Or Consequence To Patient 467 467
No Clinical Signs, Symptoms or Conditions 433 433
Blood Loss 184 184
No Information 90 90
Death 76 77
Low Oxygen Saturation 38 38
Injury 27 27
Insufficient Information 23 23
Hemorrhage/Bleeding 22 22
Thrombus 11 11
Low Blood Pressure/ Hypotension 10 10
Hypoxia 9 9
Air Embolism 8 8
No Code Available 8 8
Abnormal Blood Gases 7 7
Unspecified Infection 6 6
Sepsis 6 6
Patient Problem/Medical Problem 6 6
Hemolysis 6 6
Not Applicable 5 5
Thrombosis/Thrombus 4 4
Inflammation 4 4
Cardiac Arrest 4 4
Infarction, Cerebral 4 4
Bradycardia 3 3
Ischemia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Thromboembolism 3 3
Alteration In Body Temperature 2 2
Hematuria 2 2
Aortic Dissection 2 2
Lactate Dehydrogenase Increased 2 2
Thrombocytopenia 2 2
Heart Failure 2 2
Brain Injury 2 2
Respiratory Distress 2 2
Lupus 2 2
Neurological Deficit/Dysfunction 2 2
Stroke/CVA 2 2
Coagulation Disorder 2 2
Autoimmune Disorder 2 2
Bacterial Infection 1 2
Cardiopulmonary Arrest 1 1
Adult Respiratory Distress Syndrome 1 1
Anaphylactic Shock 1 1
Anoxia 1 1
Congestive Heart Failure 1 1
Dyspnea 1 1
Edema 1 1
Embolism 1 1
Embolus 1 1
Cardiac Enzyme Elevation 1 1
Paralysis 1 1
Pulmonary Edema 1 1
Septic Shock 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Hypothermia 1 1
Hemorrhage, Cerebral 1 1
Hyperventilation 1 1
Seizures 1 1
Disability 1 1
Laceration(s) of Esophagus 1 2
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Anxiety 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Loss of Vision 1 1
Jaundice 1 1
Iatrogenic Source 1 2
Low Cardiac Output 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC II Dec-12-2019
2 LivaNova USA II May-23-2018
3 Maquet Cardiovascular Us Sales, Llc II Dec-17-2020
4 Maquet Cardiovascular Us Sales, Llc II Sep-13-2019
5 Maquet Cardiovascular Us Sales, Llc I Nov-28-2018
6 Maquet Cardiovascular Us Sales, Llc II Apr-12-2016
7 Medtronic Inc II Dec-20-2016
8 Medtronic Perfusion Systems II Jul-04-2020
9 Terumo Cardiovascular Systems Corporation II Dec-14-2020
10 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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