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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
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 1
BAXTER HEALTHCARE CORP
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BELLCO SRL
  SUBSTANTIALLY EQUIVALENT 1
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 3
NEPHROS
  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
QUANTA DIALYSIS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRAL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 962 962
2018 1715 1715
2019 1587 1587
2020 1633 1633
2021 1944 4385
2022 1110 1110

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 4296 4541
Adverse Event Without Identified Device or Use Problem 1199 2785
Thermal Decomposition of Device 873 873
Inadequate Ultra Filtration 437 437
Leak/Splash 401 401
Break 315 315
Melted 266 266
Device Contamination with Chemical or Other Material 266 266
Crack 207 207
Disconnection 139 139
Smoking 109 109
Device Displays Incorrect Message 101 101
Improper or Incorrect Procedure or Method 94 216
Device Operates Differently Than Expected 74 74
Mechanical Problem 54 54
Protective Measures Problem 54 54
Obstruction of Flow 52 52
Charred 51 51
Reflux within Device 47 47
Device Alarm System 45 45
Sparking 44 44
Patient-Device Incompatibility 43 165
Loose or Intermittent Connection 42 42
Insufficient Information 42 164
Pressure Problem 33 33
Air/Gas in Device 32 154
Improper Flow or Infusion 30 30
Therapeutic or Diagnostic Output Failure 30 152
Filtration Problem 25 25
Fire 24 24
Connection Problem 21 21
Material Puncture/Hole 20 20
Infusion or Flow Problem 20 20
Misassembled 18 18
No Audible Alarm 18 18
Complete Blockage 18 18
Detachment of Device or Device Component 17 17
Gas Leak 15 15
Pumping Problem 15 15
Unexpected Shutdown 14 14
Detachment Of Device Component 14 14
Filling Problem 13 13
Pumping Stopped 13 13
Arcing 13 13
Defective Device 13 13
Defective Component 13 13
Use of Device Problem 12 12
Air Leak 12 12
Overheating of Device 11 11
No Flow 11 11
Output Problem 11 11
Material Split, Cut or Torn 10 10
Loss of Power 10 10
Defective Alarm 10 10
No Display/Image 10 10
Hole In Material 9 9
Material Rupture 9 131
Device Dislodged or Dislocated 9 131
Inaccurate Information 9 9
Appropriate Term/Code Not Available 8 8
Fracture 8 8
Failure to Prime 8 8
Display or Visual Feedback Problem 8 8
Partial Blockage 7 7
Failure to Infuse 7 7
Material Integrity Problem 7 7
Physical Resistance/Sticking 6 6
Component Missing 6 6
Coagulation in Device or Device Ingredient 6 6
Alarm Not Visible 6 6
Backflow 6 6
Material Discolored 5 5
Product Quality Problem 5 5
Material Perforation 5 5
Unexpected Therapeutic Results 5 5
Material Separation 5 5
Material Deformation 5 5
Packaging Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Temperature Problem 4 4
No Audible Prompt/Feedback 4 4
Biocompatibility 4 4
Increase in Pressure 4 4
Failure to Power Up 4 4
Computer Software Problem 4 4
Contamination 4 4
Use of Incorrect Control Settings 3 3
Corroded 3 3
Entrapment of Device 3 3
False Alarm 3 3
Energy Output Problem 3 3
Imprecision 3 3
Moisture Damage 3 3
Occlusion Within Device 3 3
Calibration Problem 3 3
Cut In Material 3 3
Failure to Disconnect 3 3
Communication or Transmission Problem 3 3
Electrical Shorting 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2312 2313
No Known Impact Or Consequence To Patient 2251 2251
No Patient Involvement 1233 1233
No Consequences Or Impact To Patient 1164 1164
Blood Loss 379 379
Low Blood Pressure/ Hypotension 348 714
Death 226 470
Dyspnea 183 428
Cardiac Arrest 168 534
Hypersensitivity/Allergic reaction 160 160
Loss of consciousness 144 632
Itching Sensation 143 265
Insufficient Information 116 360
Reaction 109 109
Nausea 91 458
Hemolysis 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 83 83
Vomiting 77 443
High Blood Pressure/ Hypertension 59 181
Dizziness 57 57
Hemorrhage/Bleeding 51 661
Chest Pain 48 48
Chills 47 291
Abdominal Pain 46 168
Rash 44 44
Low Oxygen Saturation 40 40
No Code Available 38 38
Cardiopulmonary Arrest 35 35
Fatigue 34 34
Headache 34 156
Chest Tightness/Pressure 33 33
Swelling 29 29
Tachycardia 29 29
Respiratory Distress 28 28
Sweating 28 150
No Information 28 28
Diaphoresis 27 28
Malaise 25 147
Hypervolemia 24 146
Weight Changes 23 23
Cramp(s) 21 21
Exsanguination 21 143
Air Embolism 20 20
Hypovolemia 19 19
Anxiety 18 18
Pain 18 18
Edema 18 18
Anemia 17 17
Bradycardia 17 17
Test Result 17 17
Respiratory Failure 15 15
Syncope 13 13
Fever 13 135
Seizures 13 13
Shock 13 135
Myocardial Infarction 12 12
Urticaria 12 134
Injury 12 12
Weakness 11 11
Confusion/ Disorientation 11 11
Loss Of Pulse 11 11
Shaking/Tremors 10 10
Peritonitis 10 10
Tingling 9 9
Swelling/ Edema 9 9
Convulsion/Seizure 8 130
Thrombocytopenia 8 252
Discomfort 8 8
Hypoxia 8 8
Bruise/Contusion 8 8
Diarrhea 8 8
Cyanosis 7 7
Fall 7 7
Muscle Weakness 7 129
Sepsis 7 129
Convulsion, Tonic 7 7
Syncope/Fainting 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Palpitations 7 7
Decreased Respiratory Rate 6 6
Cough 6 6
Alteration In Body Temperature 6 6
Skin Irritation 6 6
Erythema 6 6
Stroke/CVA 6 6
Apnea 6 128
Arrhythmia 5 5
Unspecified Infection 5 5
Hypovolemic Shock 5 5
Electrolyte Imbalance 5 5
Lethargy 5 5
Bronchospasm 5 5
Abdominal Distention 4 4
Cognitive Changes 4 4
Numbness 4 4
Fungal Infection 4 4
Diminished Pulse Pressure 4 4
Foreign Body In Patient 4 4
Distress 4 4
Hot Flashes/Flushes 4 4

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Apr-15-2022
2 Baxter Healthcare Corporation II Apr-22-2022
3 Baxter Healthcare Corporation II Nov-11-2021
4 Baxter Healthcare Corporation II Aug-27-2021
5 Baxter Healthcare Corporation II Mar-19-2021
6 Baxter Healthcare Corporation II Feb-26-2021
7 Baxter Healthcare Corporation II May-21-2020
8 Baxter Healthcare Corporation II Apr-30-2020
9 Baxter Healthcare Corporation II Feb-28-2020
10 Baxter Healthcare Corporation II Nov-04-2019
11 Baxter Healthcare Corporation II Oct-30-2019
12 Baxter Healthcare Corporation II Jul-01-2019
13 Baxter Healthcare Corporation II May-23-2018
14 Baxter Healthcare Corporation II Mar-30-2018
15 Baxter Healthcare Corporation II Jan-25-2017
16 Fresenius Medical Care Holdings, Inc. II Jun-30-2022
17 Fresenius Medical Care Holdings, Inc. II Apr-20-2020
18 Fresenius Medical Care Holdings, Inc. II Mar-20-2020
19 Fresenius Medical Care Renal Therapies Group, LLC III Jun-01-2019
20 Fresenius Medical Care Renal Therapies Group, LLC II Dec-21-2018
21 Fresenius Medical Care Renal Therapies Group, LLC II Sep-19-2018
22 Fresenius Medical Care Renal Therapies Group, LLC II Mar-20-2018
23 Fresenius Medical Care Renal Therapies Group, LLC II Feb-20-2018
24 Fresenius Medical Care Renal Therapies Group, LLC II Jan-13-2017
25 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
26 NxStage Medical, Inc. II Aug-14-2018
27 Outset Medical, Inc. II Mar-21-2022
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