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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, photopheresis, extracorporeal
Product CodeLNR
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
4 1 7 5 7 2 5 5 8 4 2 1 2 3 3 0

MDR Year MDR Reports MDR Events
2014 377 377
2015 319 319
2016 318 318
2017 261 261
2018 183 183
2019 161 161
2020 141 141
2021 114 114
2022 97 97
2023 83 83
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 845 845
Leak/Splash 659 659
Device Displays Incorrect Message 564 564
Break 408 408
Adverse Event Without Identified Device or Use Problem 151 151
Device Alarm System 90 90
Noise, Audible 82 82
Air Leak 55 55
Device Contamination with Body Fluid 55 55
Device Operates Differently Than Expected 52 52
Detachment Of Device Component 41 41
Crack 41 41
Occlusion Within Device 28 28
Hole In Material 26 26
Insufficient Information 22 22
Improper or Incorrect Procedure or Method 21 21
Detachment of Device or Device Component 18 18
Device Dislodged or Dislocated 18 18
Coagulation in Device or Device Ingredient 18 18
Disconnection 17 17
Pressure Problem 17 17
Protective Measures Problem 16 16
Use of Device Problem 14 14
Material Puncture/Hole 12 12
Loose or Intermittent Connection 11 11
Torn Material 11 11
Gas/Air Leak 11 11
Unintended Ejection 10 10
Material Fragmentation 10 10
Defective Alarm 9 9
Output Problem 9 9
Obstruction of Flow 9 9
Visual Prompts will not Clear 8 8
Burst Container or Vessel 8 8
Display or Visual Feedback Problem 8 8
Bent 7 7
Failure to Prime 7 7
Material Separation 7 7
Infusion or Flow Problem 7 7
Split 6 6
Loss of Power 6 6
Device Emits Odor 6 6
Component Falling 5 5
Positioning Problem 5 5
Physical Property Issue 4 4
Material Twisted/Bent 4 4
Moisture or Humidity Problem 4 4
Malposition of Device 4 4
Defective Component 4 4
Fitting Problem 4 4
Vibration 4 4
Cut In Material 4 4
Kinked 4 4
Increase in Pressure 4 4
Sticking 4 4
Material Rupture 4 4
Air/Gas in Device 4 4
Unexpected Therapeutic Results 3 3
Device Slipped 3 3
Smoking 3 3
Contamination 3 3
Complete Blockage 3 3
Partial Blockage 3 3
False Alarm 3 3
Filling Problem 3 3
High Test Results 3 3
Insufficient Flow or Under Infusion 3 3
Component Missing 3 3
Structural Problem 3 3
Expulsion 3 3
Improper Flow or Infusion 3 3
Failure to Shut Off 3 3
Misassembly by Users 3 3
Problem with Software Installation 2 2
Connection Problem 2 2
Material Protrusion/Extrusion 2 2
Device Contamination with Chemical or Other Material 2 2
Free or Unrestricted Flow 2 2
Inadequate User Interface 2 2
Installation-Related Problem 2 2
Chemical Spillage 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Volume Accuracy Problem 2 2
False Reading From Device Non-Compliance 2 2
No Display/Image 2 2
Material Frayed 2 2
Fogging 2 2
Fracture 2 2
Excess Flow or Over-Infusion 2 2
No Audible Alarm 2 2
Thermal Decomposition of Device 2 2
Device Inoperable 2 2
Difficult to Remove 2 2
Particulates 2 2
Misassembled 2 2
Misconnection 2 2
Incorrect Measurement 2 2
Mechanical Problem 2 2
Appropriate Term/Code Not Available 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 866 866
No Clinical Signs, Symptoms or Conditions 316 316
Blood Loss 211 211
No Consequences Or Impact To Patient 204 204
Hemorrhage/Bleeding 120 120
No Information 53 53
No Code Available 53 53
Low Blood Pressure/ Hypotension 50 50
Dyspnea 37 37
Pulmonary Embolism 32 32
Thrombosis 27 27
Nausea 20 20
Death 20 21
Anemia 19 19
Tachycardia 17 17
Malaise 16 16
Unspecified Infection 14 14
Thrombus 14 14
Chest Pain 13 13
Dizziness 12 12
No Patient Involvement 12 12
Low Oxygen Saturation 12 12
Patient Problem/Medical Problem 11 11
Insufficient Information 11 11
Fever 10 10
Swelling 10 10
High Blood Pressure/ Hypertension 10 10
Pain 9 9
Hypoxia 9 9
Fainting 9 9
Vomiting 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Fatigue 8 8
Headache 7 7
Test Result 7 7
Pallor 7 7
Tingling 7 7
Complaint, Ill-Defined 6 6
Chills 5 5
Reaction 5 5
Weakness 5 5
Respiratory Failure 5 5
Multiple Organ Failure 5 5
Hyperglycemia 5 5
Abdominal Pain 5 5
Itching Sensation 5 5
Respiratory Distress 5 5
Sepsis 4 4
Hypoglycemia 4 4
Bacterial Infection 4 4
Diarrhea 4 4
Hypersensitivity/Allergic reaction 4 4
Hemolysis 4 4
Numbness 4 4
Loss of consciousness 3 3
Sweating 3 3
Discomfort 3 3
Anxiety 3 3
Blurred Vision 3 3
Hematuria 3 3
Ambulation Difficulties 3 3
Paresthesia 3 3
Cyanosis 3 3
Stroke/CVA 3 3
Exposure to Body Fluids 3 3
Air Embolism 3 3
Seizures 3 3
Pulmonary Edema 3 3
Rash 3 3
Skin Discoloration 3 3
Shock 2 2
Pulmonary Infarction 2 2
Pneumonia 2 2
Internal Organ Perforation 2 2
Bradycardia 2 2
Atrial Fibrillation 2 2
Edema 2 2
Erythema 2 2
Hematoma 2 2
Syncope/Fainting 2 2
Cough 2 2
Wheezing 2 2
Confusion/ Disorientation 2 2
Therapeutic Effects, Unexpected 2 2
Burning Sensation 2 2
Brain Injury 2 2
Toxicity 2 2
Chest Tightness/Pressure 2 2
Neck Pain 2 2
Collapse 2 2
Fungal Infection 1 1
Bronchopneumonia 1 1
Reinfusion 1 1
Distress 1 1
Urticaria 1 1
Heart Failure 1 1
Hypoxia in Utero 1 1
Twitching 1 1
Electrolyte Imbalance 1 1
Hot Flashes/Flushes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mallinckrodt Pharmaceuticals Ireland Ltd II Feb-07-2022
2 Therakos Inc II Apr-05-2016
3 Therakos Inc II Jul-19-2011
4 Therakos Inc II Apr-28-2011
5 Therakos Inc II May-26-2010
6 Therakos, Inc. II Nov-05-2021
7 Therakos, Inc. II Jan-11-2012
8 Therakos, Inc. II Aug-10-2011
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