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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
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 1
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 4
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
2017 388 388
2018 321 321
2019 489 489
2020 442 442
2021 595 595
2022 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 399 399
Fluid Leak 217 217
Break 202 202
Infusion or Flow Problem 143 143
Increase in Pressure 126 126
Pressure Problem 111 111
Packaging Problem 101 101
Use of Device Problem 79 79
Coagulation in Device or Device Ingredient 72 72
Crack 70 70
Detachment of Device or Device Component 57 57
Device Operates Differently Than Expected 52 52
Unable to Obtain Readings 52 52
Defective Component 47 47
Obstruction of Flow 47 47
Insufficient Flow or Under Infusion 37 37
Improper Flow or Infusion 36 36
Manufacturing, Packaging or Shipping Problem 36 36
Adverse Event Without Identified Device or Use Problem 34 34
Material Deformation 31 31
Gas Output Problem 29 29
Fracture 27 27
Device Damaged Prior to Use 27 27
Connection Problem 25 25
Failure to Deliver 24 24
Defective Device 24 24
No Flow 24 24
Material Separation 24 24
Disconnection 23 23
Medical Gas Supply Problem 23 23
Contamination 20 20
Component Missing 19 19
Device Operational Issue 19 19
Device Sensing Problem 19 19
Insufficient Information 18 18
Noise, Audible 17 17
Improper Chemical Reaction 17 17
Decrease in Pressure 17 17
Mechanical Problem 17 17
Device Difficult to Setup or Prepare 16 16
Filtration Problem 16 16
Contamination /Decontamination Problem 15 15
Complete Blockage 15 15
Loose or Intermittent Connection 14 14
Air/Gas in Device 14 14
Shipping Damage or Problem 13 13
Low Readings 13 13
Inaccurate Delivery 13 13
Gas Leak 12 12
Output Problem 11 11
Tear, Rip or Hole in Device Packaging 11 11
Restricted Flow rate 10 10
Detachment Of Device Component 10 10
Pumping Stopped 9 9
Particulates 9 9
Dent in Material 9 9
Scratched Material 9 9
Partial Blockage 8 8
Air Leak 8 8
Material Integrity Problem 7 7
Device Contamination with Chemical or Other Material 7 7
Blocked Connection 6 6
Temperature Problem 6 6
Gradient Increase 5 5
Insufficient Heating 5 5
Failure to Prime 5 5
Failure to Sense 5 5
Out-Of-Box Failure 5 5
Device Inoperable 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Material Discolored 4 4
Misassembled 4 4
Loss of or Failure to Bond 4 4
Clumping in Device or Device Ingredient 4 4
Device Contaminated During Manufacture or Shipping 4 4
Incorrect Device Or Component Shipped 4 4
Device Markings/Labelling Problem 4 4
Device Issue 4 4
Free or Unrestricted Flow 3 3
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 3 3
No Device Output 3 3
Unexpected Therapeutic Results 3 3
Fitting Problem 3 3
Incomplete or Missing Packaging 3 3
Microbial Contamination of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Melted 2 2
Circuit Failure 2 2
Incorrect Measurement 2 2
Labelling, Instructions for Use or Training Problem 2 2
Inaccurate Flow Rate 2 2
Material Fragmentation 2 2
Patient Device Interaction Problem 2 2
No Apparent Adverse Event 2 2
Pumping Problem 2 2
Output below Specifications 2 2
Improper Device Output 2 2
Device Dislodged or Dislocated 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 778 778
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
No Information 74 74
Death 59 60
Insufficient Information 38 38
Hemorrhage/Bleeding 33 33
Low Oxygen Saturation 33 33
Injury 27 27
Hypoxia 14 14
Low Blood Pressure/ Hypotension 12 12
Cardiac Arrest 11 11
Air Embolism 8 8
Hemolysis 8 8
Unspecified Infection 7 7
Abnormal Blood Gases 6 6
Sepsis 6 6
Thrombus 6 6
No Code Available 5 5
Infarction, Cerebral 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Thrombosis/Thrombus 4 4
Inflammation 3 3
Bradycardia 3 3
Hypothermia 3 3
Thrombocytopenia 3 3
Thromboembolism 3 3
Patient Problem/Medical Problem 3 3
Respiratory Failure 3 3
Aortic Dissection 2 2
Hematuria 2 2
Alteration In Body Temperature 2 2
Septic Shock 2 2
Heart Failure 2 2
Hypovolemia 2 2
Ischemia 2 2
Lupus 2 2
Neurological Deficit/Dysfunction 2 2
Anemia 2 2
Autoimmune Disorder 2 2
Lactate Dehydrogenase Increased 2 2
Bacterial Infection 1 2
Anoxia 1 1
Adult Respiratory Distress Syndrome 1 1
Anaphylactic Shock 1 1
Coagulation Disorder 1 1
Congestive Heart Failure 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 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
Respiratory Distress 1 1
Seizures 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 1 1
Anxiety 1 1
Brain Injury 1 1
Disability 1 1
Laceration(s) of Esophagus 1 2
Loss of consciousness 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Jaundice 1 1
Not Applicable 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

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 Medtronic Perfusion Systems II Jul-04-2020
8 Terumo Cardiovascular Systems Corporation II Dec-14-2020
9 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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