• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K183490  Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
  2.  K183511  Affinity Pixie™ Oxygenator with Balance™ Biosurfac ...
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K183490  Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
  2.  K183511  Affinity Pixie™ Oxygenator with Balance™ Biosurfac ...
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
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 595 595

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 432 432
Fluid Leak 203 203
Break 200 200
Increase in Pressure 144 144
Pressure Problem 139 139
Infusion or Flow Problem 127 127
Use of Device Problem 91 91
Packaging Problem 88 88
Coagulation in Device or Device Ingredient 77 77
Device Operates Differently Than Expected 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
Adverse Event Without Identified Device or Use Problem 38 38
Insufficient Flow or Under Infusion 37 37
Device Contamination with Chemical or Other Material 35 35
Connection Problem 35 35
Device Damaged Prior to Use 33 33
Obstruction of Flow 32 32
Material Deformation 28 28
Air Leak 28 28
Manufacturing, Packaging or Shipping Problem 27 27
No Flow 25 25
Disconnection 25 25
Component Missing 23 23
Device Operational Issue 23 23
Defective Device 22 22
Insufficient Information 22 22
Medical Gas Supply Problem 22 22
Failure to Deliver 21 21
Gas Output Problem 20 20
Complete Blockage 19 19
Material Separation 19 19
Mechanical Problem 17 17
Filtration Problem 17 17
Detachment Of Device Component 16 16
Contamination 15 15
Device Difficult to Setup or Prepare 15 15
Decrease in Pressure 15 15
Tear, Rip or Hole in Device Packaging 15 15
Device Sensing Problem 15 15
Temperature Problem 14 14
Loose or Intermittent Connection 14 14
Contamination /Decontamination Problem 13 13
Low Readings 12 12
Inaccurate Delivery 12 12
Noise, Audible 12 12
Gas Leak 12 12
Improper Chemical Reaction 12 12
Shipping Damage or Problem 12 12
Device Issue 11 11
Restricted Flow rate 10 10
Partial Blockage 9 9
Occlusion Within Device 9 9
Output Problem 9 9
Air/Gas in Device 8 8
Incorrect Device Or Component Shipped 7 7
Material Integrity Problem 7 7
Device Displays Incorrect Message 7 7
Particulates 7 7
Failure to Prime 6 6
Material Discolored 6 6
Out-Of-Box Failure 6 6
Improper or Incorrect Procedure or Method 5 5
Blocked Connection 5 5
Insufficient Heating 5 5
Device Inoperable 5 5
Failure to Sense 4 4
Misassembled 4 4
Pumping Stopped 4 4
Circuit Failure 4 4
Device Alarm System 4 4
Device Markings/Labelling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Appropriate Term/Code Not Available 4 4
Therapeutic or Diagnostic Output Failure 3 3
Pumping Problem 3 3
Improper Device Output 3 3
Free or Unrestricted Flow 3 3
Loss of or Failure to Bond 3 3
No Display/Image 3 3
Gradient Increase 3 3
No Device Output 3 3
Kinked 3 3
Fitting Problem 3 3
Material Split, Cut or Torn 3 3
Suction Failure 2 2
Scratched Material 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
False Reading From Device Non-Compliance 2 2
Excess Flow or Over-Infusion 2 2
Labelling, Instructions for Use or Training Problem 2 2
Incorrect Measurement 2 2
Melted 2 2
Inaccurate Flow Rate 2 2
Material Fragmentation 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 Clinical Signs, Symptoms or Conditions 515 515
No Known Impact Or Consequence To Patient 467 467
Blood Loss 184 184
No Information 90 90
Death 76 77
Low Oxygen Saturation 38 38
Injury 27 27
Insufficient Information 24 24
Hemorrhage/Bleeding 22 22
Low Blood Pressure/ Hypotension 13 13
Hypoxia 12 12
Thrombus 11 11
Air Embolism 9 9
No Code Available 8 8
Hemolysis 7 7
Abnormal Blood Gases 7 7
Unspecified Infection 6 6
Sepsis 6 6
Patient Problem/Medical Problem 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
Hypothermia 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
Hemorrhage, Cerebral 1 1
Hyperventilation 1 1
Septic Shock 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 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
-
-