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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, pump, cardiopulmonary bypass
Product CodeDWE
Regulation Number 870.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VORTEX MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 129 129
2015 133 133
2016 151 151
2017 131 131
2018 134 134
2019 82 82
2020 45 45
2021 41 41
2022 123 123
2023 287 287
2024 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 429 429
Leak/Splash 146 146
Device Operates Differently Than Expected 103 103
Crack 50 50
Disconnection 48 48
Obstruction of Flow 45 45
Material Separation 41 41
Material Puncture/Hole 41 41
Material Deformation 34 34
Air/Gas in Device 29 29
Noise, Audible 27 27
Misassembled 27 27
Improper Flow or Infusion 24 24
Defective Component 23 23
Break 22 22
Air Leak 19 19
Loose or Intermittent Connection 19 19
Pressure Problem 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Filtration Problem 17 17
Device Displays Incorrect Message 17 17
Infusion or Flow Problem 16 16
Kinked 16 16
Increase in Pressure 16 16
No Flow 16 16
Detachment Of Device Component 14 14
Device Misassembled During Manufacturing /Shipping 14 14
Tear, Rip or Hole in Device Packaging 14 14
Failure to Prime 13 13
Misassembled During Installation 13 13
Connection Problem 12 12
Packaging Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Mechanical Problem 11 11
Occlusion Within Device 11 11
Insufficient Flow or Under Infusion 10 10
Insufficient Information 10 10
Pumping Problem 8 8
Component Missing 8 8
Gas/Air Leak 8 8
Restricted Flow rate 8 8
Material Discolored 8 8
Hole In Material 8 8
Complete Blockage 6 6
Device Contamination with Chemical or Other Material 6 6
Detachment of Device or Device Component 6 6
Output Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Defective Device 6 6
Material Split, Cut or Torn 6 6
Temperature Problem 5 5
Malfunction 5 5
Device Damaged Prior to Use 5 5
Device Inoperable 5 5
Use of Device Problem 5 5
Material Integrity Problem 5 5
Decoupling 5 5
Fracture 5 5
Material Fragmentation 5 5
Nonstandard Device 5 5
Difficult to Remove 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Pumping Stopped 4 4
Incorrect Measurement 4 4
No Display/Image 4 4
Contamination 4 4
Coagulation in Device or Device Ingredient 4 4
Device Dislodged or Dislocated 4 4
Device Markings/Labelling Problem 4 4
Improper Device Output 4 4
No Apparent Adverse Event 4 4
Component Misassembled 4 4
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 3 3
Torn Material 3 3
Device Slipped 3 3
Device Contamination with Body Fluid 3 3
Blocked Connection 3 3
Partial Blockage 3 3
Display or Visual Feedback Problem 3 3
Misconnection 3 3
Decrease in Pressure 3 3
Off-Label Use 2 2
Particulates 2 2
Unable to Obtain Readings 2 2
Moisture Damage 2 2
Delivered as Unsterile Product 2 2
No Device Output 2 2
Inaccurate Flow Rate 2 2
Component(s), broken 2 2
Gas Output Problem 2 2
Loss of or Failure to Bond 2 2
Bent 2 2
Malposition of Device 2 2
Labeling, missing 2 2
Incorrect Or Inadequate Test Results 2 2
Shipping Damage or Problem 2 2
Free or Unrestricted Flow 2 2
Chemical Problem 2 2
Communication or Transmission Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 487 487
No Known Impact Or Consequence To Patient 360 360
No Consequences Or Impact To Patient 200 200
No Patient Involvement 97 97
Hemorrhage/Bleeding 87 87
Death 48 48
No Information 24 24
Blood Loss 20 20
Low Oxygen Saturation 14 14
Hemolysis 9 9
No Code Available 7 7
Insufficient Information 6 6
Hypovolemia 6 6
Air Embolism 5 5
Bradycardia 5 5
Cardiac Arrest 5 5
Hypoxia 5 5
Unspecified Infection 5 5
Low Blood Pressure/ Hypotension 4 4
Thrombus 4 4
Injury 4 4
Ischemia 3 3
Myocardial Infarction 2 2
Stroke/CVA 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Exsanguination 2 2
Complaint, Ill-Defined 2 2
Brain Injury 2 2
Thrombosis 2 2
No Patient involvement 2 2
Patient Problem/Medical Problem 1 1
Pericardial Effusion 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Discomfort 1 1
Transient Ischemic Attack 1 1
Perforation of Vessels 1 1
Hypothermia 1 1
Toxicity 1 1
Collapse 1 1
Coma 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Cardiac Perforation 1 1
Vascular System (Circulation), Impaired 1 1
Internal Organ Perforation 1 1
Paralysis 1 1
Pneumonia 1 1
Renal Failure 1 1
Surgical procedure, repeated 1 1
Sepsis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II May-20-2016
2 Datascope Corporation II Oct-11-2018
3 Datascope Corporation III Jun-06-2018
4 Datascope Corporation II May-08-2018
5 Datascope Corporation II Mar-23-2017
6 Datascope Corporation II Jun-15-2016
7 LivaNova USA III Feb-21-2018
8 LivaNova USA Inc. III Feb-27-2020
9 Maquet II Dec-20-2017
10 Maquet Cardiovascular, LLC III Mar-16-2011
11 Maquet Inc. II Oct-06-2010
12 Maquet Inc. II Sep-12-2010
13 Medtronic Cardiovascular Revascularization & Surgical Therap II Jun-23-2009
14 Medtronic Inc. Cardiac Rhythm Disease Management II Feb-20-2014
15 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
16 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
17 Medtronic Perfusion Systems II Sep-04-2015
18 Sorin Group USA, Inc. II Jul-29-2017
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