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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dialyzer, high permeability with or without sealed dialysate system
Regulation Description High permeability hemodialysis system.
Product CodeKDI
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ASAHI KASEI MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN AVITUM AG
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BELLCO SRL
  SUBSTANTIALLY EQUIVALENT 2
CHF SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIALCO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE REANAL THERAPIES GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 4
NIKKISO, CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
QUANTA DIALYSIS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRAL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 766 766
2017 962 962
2018 1715 1715
2019 1587 1587
2020 1633 1633
2021 911 3352

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 2962 3207
Adverse Event Without Identified Device or Use Problem 1161 2747
Thermal Decomposition of Device 843 843
Leak/Splash 406 406
Inadequate Ultra Filtration 391 391
Melted 281 281
Device Contamination with Chemical or Other Material 230 230
Break 225 225
Device Operates Differently Than Expected 211 211
Mechanical Problem 158 158
Crack 157 157
Reflux within Device 153 153
Disconnection 132 132
Insufficient Information 120 242
Smoking 110 110
Device Displays Incorrect Message 102 102
Improper or Incorrect Procedure or Method 78 200
Charred 67 67
Device Alarm System 55 55
Sparking 40 40
Patient-Device Incompatibility 38 160
Connection Problem 34 34
Protective Measures Problem 33 33
Pressure Problem 32 32
Loose or Intermittent Connection 31 31
Complete Blockage 28 28
Obstruction of Flow 27 27
Overheating of Device 24 24
Improper Flow or Infusion 23 23
Fire 22 22
Pumping Stopped 20 20
Therapeutic or Diagnostic Output Failure 20 142
Air Leak 19 19
Pumping Problem 18 18
Misassembled 18 18
Coagulation in Device or Device Ingredient 18 18
Computer Software Problem 18 18
Infusion or Flow Problem 17 17
Detachment Of Device Component 16 16
No Audible Alarm 14 14
Filling Problem 14 14
Material Puncture/Hole 14 14
Detachment of Device or Device Component 14 14
Device Dislodged or Dislocated 13 135
Filtration Problem 13 13
Use of Device Problem 13 13
Contamination 13 13
Defective Component 11 11
Gas Leak 11 11
No Flow 11 11
No Display/Image 10 10
Arcing 10 10
Air/Gas in Device 9 131
Hole In Material 9 9
Defective Device 8 8
Unexpected Shutdown 8 8
Material Rupture 8 130
Occlusion Within Device 8 8
Backflow 7 7
Failure to Infuse 7 7
Appropriate Term/Code Not Available 7 7
Fracture 7 7
Loss of Power 7 7
Failure to Prime 6 6
Output Problem 6 6
Packaging Problem 5 5
Temperature Problem 5 5
Material Split, Cut or Torn 5 5
Component Missing 5 5
Partial Blockage 5 5
Defective Alarm 5 5
Alarm Not Visible 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Physical Resistance/Sticking 4 4
Material Discolored 4 4
Product Quality Problem 4 4
Entrapment of Device 4 4
Unexpected Therapeutic Results 4 4
Material Perforation 4 4
Calibration Problem 4 4
Display or Visual Feedback Problem 4 4
Particulates 3 3
Nonstandard Device 3 3
Communication or Transmission Problem 3 3
Device Issue 3 3
Cut In Material 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Material Separation 3 3
Operating System Becomes Nonfunctional 3 3
No Audible Prompt/Feedback 3 3
Device Contamination with Body Fluid 3 3
Biocompatibility 3 3
Electrical Shorting 3 3
Imprecision 3 3
False Alarm 3 3
Corroded 3 3
No Visual Prompts/Feedback 3 3
Material Deformation 3 3
Material Integrity Problem 3 3
Unintended Movement 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2403 2403
No Patient Involvement 1422 1422
No Consequences Or Impact To Patient 1206 1206
No Clinical Signs, Symptoms or Conditions 572 573
Blood Loss 484 484
Low Blood Pressure/ Hypotension 333 699
Death 301 545
Cardiac Arrest 182 548
Hypersensitivity/Allergic reaction 168 168
Dyspnea 159 404
Loss of consciousness 137 625
Itching Sensation 137 259
Reaction 118 118
Hemolysis 88 88
Nausea 82 449
Vomiting 64 430
Insufficient Information 49 293
Chills 48 292
Cardiopulmonary Arrest 47 47
High Blood Pressure/ Hypertension 47 169
No Code Available 47 47
Chest Pain 42 42
No Information 41 41
Dizziness 40 40
Rash 40 40
Abdominal Pain 38 160
Chest Tightness/Pressure 37 37
Fatigue 33 33
Low Oxygen Saturation 33 33
Swelling 31 31
Headache 30 152
Tachycardia 30 30
Respiratory Distress 29 29
Hemorrhage/Bleeding 28 638
Sweating 28 150
Cramp(s) 27 27
Hypervolemia 27 149
Pain 26 26
Malaise 26 148
Fever 23 145
Syncope 20 20
Bradycardia 20 20
Seizures 19 19
Anxiety 18 18
Edema 18 18
Exsanguination 18 140
Diaphoresis 18 19
Test Result 17 17
Air Embolism 16 16
Anemia 16 16
Urticaria 14 136
Loss Of Pulse 13 13
Hypovolemia 13 13
Respiratory Failure 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Injury 12 12
Shock 12 134
Myocardial Infarction 11 11
Weakness 11 11
Weight Changes 11 11
Tingling 10 10
Hypoxia 9 9
Shaking/Tremors 9 9
Confusion/ Disorientation 8 8
Bruise/Contusion 8 8
Stroke/CVA 7 7
Peritonitis 7 7
Palpitations 7 7
Convulsion, Tonic 7 7
Erythema 7 7
Sepsis 6 128
Skin Irritation 6 6
Cyanosis 6 6
Diarrhea 6 6
Apnea 6 128
Electrolyte Imbalance 6 6
Alteration In Body Temperature 6 6
Foreign Body In Patient 5 5
Patient Problem/Medical Problem 5 5
Bronchospasm 5 5
Arrhythmia 5 5
Anaphylactic Shock 5 5
Angina 5 5
Hypoglycemia 5 5
Dehydration 5 5
Fainting 5 5
Fall 5 5
Thrombus 5 5
Anaphylactoid 5 5
Lethargy 5 5
Numbness 4 4
Pulmonary Embolism 4 4
Congestive Heart Failure 4 4
Infiltration into Tissue 4 4
Unspecified Infection 4 4
Distress 4 4
Discomfort 4 4
Pulmonary Edema 4 4
Local Reaction 3 3
Pneumonia 3 3

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc I May-03-2016
2 Baxter Healthcare Corporation II Mar-19-2021
3 Baxter Healthcare Corporation II Feb-26-2021
4 Baxter Healthcare Corporation II May-21-2020
5 Baxter Healthcare Corporation II Apr-30-2020
6 Baxter Healthcare Corporation II Feb-28-2020
7 Baxter Healthcare Corporation II Nov-04-2019
8 Baxter Healthcare Corporation II Oct-30-2019
9 Baxter Healthcare Corporation II Jul-01-2019
10 Baxter Healthcare Corporation II May-23-2018
11 Baxter Healthcare Corporation II Mar-30-2018
12 Baxter Healthcare Corporation II Jan-25-2017
13 Fresenius Medical Care Holdings, Inc. II Apr-20-2020
14 Fresenius Medical Care Holdings, Inc. II Mar-20-2020
15 Fresenius Medical Care Renal Therapies Group, LLC III Jun-01-2019
16 Fresenius Medical Care Renal Therapies Group, LLC II Dec-21-2018
17 Fresenius Medical Care Renal Therapies Group, LLC II Sep-19-2018
18 Fresenius Medical Care Renal Therapies Group, LLC II Mar-20-2018
19 Fresenius Medical Care Renal Therapies Group, LLC II Feb-20-2018
20 Fresenius Medical Care Renal Therapies Group, LLC II Jan-13-2017
21 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016
22 NxStage Medical, Inc. II Aug-14-2018
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