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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
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHALICE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 3
EUROSETS S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 11
MEDOS MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 3
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 15
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 763 763
2015 658 658
2016 443 443
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
Leak/Splash 1121 1121
Fluid/Blood Leak 1050 1050
Break 303 303
Increase in Pressure 276 276
Use of Device Problem 215 215
Pressure Problem 212 212
Infusion or Flow Problem 207 207
Device Operates Differently Than Expected 180 180
Material Separation 145 145
Crack 143 143
Packaging Problem 123 123
Device Damaged Prior to Use 111 111
Coagulation in Device or Device Ingredient 110 110
Obstruction of Flow 94 94
Improper Flow or Infusion 75 75
Adverse Event Without Identified Device or Use Problem 70 70
Material Deformation 68 68
Connection Problem 68 68
Defective Component 68 68
Gas Output Problem 66 66
Detachment of Device or Device Component 62 62
Unable to Obtain Readings 60 60
Filtration Problem 58 58
Disconnection 57 57
Fracture 56 56
Device Contamination with Chemical or Other Material 53 53
Insufficient Information 52 52
Insufficient Flow or Under Infusion 52 52
Air Leak 51 51
Manufacturing, Packaging or Shipping Problem 46 46
Medical Gas Supply Problem 45 45
No Flow 40 40
Shipping Damage or Problem 39 39
Other (for use when an appropriate device code cannot be identified) 37 37
Contamination 36 36
Occlusion Within Device 35 35
Partial Blockage 34 34
Complete Blockage 32 32
Decrease in Pressure 32 32
Air/Gas in Device 30 30
Gas/Air Leak 29 29
Device Sensing Problem 29 29
Component Missing 27 27
Output Problem 27 27
Device Operational Issue 26 26
Gradient Increase 26 26
Mechanical Problem 25 25
Defective Device 25 25
Device Issue 25 25
Unexpected Therapeutic Results 25 25
Material Puncture/Hole 25 25
Temperature Problem 25 25
Failure to Deliver 24 24
Improper Chemical Reaction 23 23
Noise, Audible 23 23
Loose or Intermittent Connection 22 22
Tear, Rip or Hole in Device Packaging 20 20
Low Readings 20 20
Particulates 19 19
Detachment Of Device Component 17 17
Contamination /Decontamination Problem 17 17
Inaccurate Delivery 17 17
Device Difficult to Setup or Prepare 16 16
Pumping Stopped 14 14
Restricted Flow rate 14 14
Dent in Material 14 14
Device Displays Incorrect Message 13 13
Scratched Material 12 12
Failure to Prime 11 11
Blocked Connection 10 10
Appropriate Term/Code Not Available 10 10
Material Integrity Problem 9 9
Device Markings/Labelling Problem 9 9
Out-Of-Box Failure 9 9
Improper or Incorrect Procedure or Method 9 9
Nonstandard Device 9 9
Device Alarm System 9 9
Failure to Sense 8 8
Incorrect Device Or Component Shipped 8 8
Pumping Problem 7 7
Device Inoperable 7 7
Fitting Problem 7 7
Loss of or Failure to Bond 7 7
Material Discolored 7 7
Failure To Adhere Or Bond 6 6
Insufficient Heating 6 6
Material Rupture 6 6
High Readings 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Hole In Material 5 5
Misassembled 5 5
Delivered as Unsterile Product 5 5
Clumping in Device or Device Ingredient 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Split, Cut or Torn 5 5
Misassembled During Installation 4 4
Patient Device Interaction Problem 4 4
Unintended Movement 4 4
Material Twisted/Bent 4 4
Circuit Failure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1756 1756
No Known Impact Or Consequence To Patient 1118 1118
No Patient Involvement 969 969
No Consequences Or Impact To Patient 804 804
Blood Loss 278 278
Death 133 134
No Information 132 132
Hemorrhage/Bleeding 118 118
Insufficient Information 90 90
Low Oxygen Saturation 59 59
Injury 31 31
Hypoxia 28 28
Cardiac Arrest 27 27
Abnormal Blood Gases 21 21
Hemolysis 21 21
Low Blood Pressure/ Hypotension 20 20
Air Embolism 17 17
Thrombus 15 15
Sepsis 14 14
No Code Available 14 14
Not Applicable 12 12
Unspecified Infection 10 10
Stroke/CVA 8 8
Coagulation Disorder 8 8
Anemia 7 7
Ischemia 6 6
Bradycardia 6 6
Patient Problem/Medical Problem 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Thrombosis/Thrombus 6 6
No Patient involvement 6 6
Inflammation 4 4
Infarction, Cerebral 4 4
Hypothermia 3 3
Neurological Deficit/Dysfunction 3 3
Renal Failure 3 3
Respiratory Distress 3 3
Thromboembolism 3 3
Hematuria 3 3
Respiratory Failure 3 3
Ischemia Stroke 3 3
Thrombocytopenia 3 3
Asystole 2 2
Lactate Dehydrogenase Increased 2 2
Swelling/ Edema 2 2
Respiratory Acidosis 2 2
Aortic Dissection 2 2
Pulmonary Edema 2 2
Alteration In Body Temperature 2 2
Pneumonia 2 2
Septic Shock 2 2
Heart Failure 2 2
Brain Injury 2 2
Hypovolemia 2 2
Lupus 2 2
Hemorrhage, Cerebral 2 2
Embolism 2 2
Exsanguination 2 2
Hematoma 2 2
Anoxia 2 2
Autoimmune Disorder 2 2
Bacterial Infection 1 2
Exposure to Body Fluids 1 1
Anaphylactic Shock 1 1
Adult Respiratory Distress Syndrome 1 1
Chest Pain 1 1
Cardiopulmonary Arrest 1 1
Congestive Heart Failure 1 1
Dyspnea 1 1
Edema 1 1
Embolus 1 1
Cardiac Enzyme Elevation 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperventilation 1 1
Myocardial Infarction 1 1
Hypoventilation 1 1
Cardiogenic Shock 1 1
Anxiety 1 1
Rupture 1 1
Unknown (for use when the patient's condition is not known) 1 1
Foreign body, removal of 1 1
Disability 1 1
Reintubate 1 1
Laceration(s) of Esophagus 1 2
Loss of consciousness 1 1
Fungal Infection 1 1
Pallor 1 1
Myocarditis 1 1
Shock 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Loss of Vision 1 1
Jaundice 1 1
Concussion 1 1
Pulmonary Dysfunction 1 1
Paralysis 1 1
Seizures 1 1
Surgical procedure, repeated 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 Cardiovascular Us Sales, Llc II Apr-12-2016
8 Maquet Cardiovascular Us Sales, Llc II May-28-2015
9 Maquet Cardiovascular Us Sales, Llc II Dec-24-2014
10 Maquet Cardiovascular Us Sales, Llc II Sep-20-2013
11 Maquet Cardiovascular Us Sales, Llc II Oct-26-2012
12 Maquet Cardiovascular Us Sales, Llc II Jan-11-2012
13 Maquet Medical Systems USA II Feb-13-2024
14 Maquet Medical Systems USA II May-30-2023
15 Maquet Medical Systems USA II May-26-2023
16 Maquet Medical Systems USA II Feb-28-2023
17 Maquet Medical Systems USA II Sep-19-2022
18 Medtronic Inc II Dec-20-2016
19 Medtronic Inc II Feb-09-2009
20 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
21 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
22 Medtronic Perfusion Systems II Jan-27-2023
23 Medtronic Perfusion Systems II Jul-04-2020
24 Medtronic Perfusion Systems II Dec-16-2014
25 Sorin Group USA, Inc. II Jan-14-2012
26 Terumo Cardiovascular Corporation III Jan-24-2012
27 Terumo Cardiovascular Systems Corp II May-11-2012
28 Terumo Cardiovascular Systems Corporation II Apr-05-2023
29 Terumo Cardiovascular Systems Corporation II Dec-14-2020
30 Terumo Cardiovascular Systems Corporation II Jul-30-2019
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