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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
BAXTER HEALTHCARE CORP
  SUBSTANTIALLY EQUIVALENT 1
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 REANAL THERAPIES GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 5
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
QUANTA DIALYSIS TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
QUANTA DIALYSIS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1715 1715
2019 1587 1587
2020 1633 1633
2021 1944 4385
2022 2183 2183

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4811 5056
Adverse Event Without Identified Device or Use Problem 1080 2666
Thermal Decomposition of Device 816 816
Inadequate Ultra Filtration 384 384
Leak/Splash 343 343
Break 328 328
Device Contamination with Chemical or Other Material 278 278
Melted 250 250
Crack 208 208
Disconnection 132 132
Improper or Incorrect Procedure or Method 100 222
Smoking 93 93
Device Displays Incorrect Message 87 87
Obstruction of Flow 57 57
Protective Measures Problem 57 57
Device Alarm System 52 52
Air/Gas in Device 45 167
Patient-Device Incompatibility 41 163
Improper Flow or Infusion 39 39
Loose or Intermittent Connection 38 38
Device Operates Differently Than Expected 36 36
Sparking 34 34
Mechanical Problem 33 33
Therapeutic or Diagnostic Output Failure 31 153
Insufficient Information 25 147
Reflux within Device 25 25
Filtration Problem 25 25
Charred 24 24
Material Puncture/Hole 23 23
Fire 21 21
Infusion or Flow Problem 21 21
Detachment of Device or Device Component 20 20
No Audible Alarm 19 19
Misassembled 18 18
Defective Device 17 17
Complete Blockage 16 16
Unexpected Shutdown 16 16
Gas/Air Leak 15 15
No Display/Image 14 14
Defective Component 14 14
Arcing 13 13
No Flow 13 13
Output Problem 13 13
Material Split, Cut or Torn 13 13
Pressure Problem 12 12
Device Dislodged or Dislocated 12 134
Filling Problem 12 12
Display or Visual Feedback Problem 11 11
Overheating of Device 11 11
Connection Problem 11 11
Defective Alarm 10 10
Inaccurate Information 9 9
Material Integrity Problem 8 8
Physical Resistance/Sticking 8 8
Loss of Power 8 8
Failure to Prime 8 8
Use of Device Problem 8 8
Material Rupture 8 130
Failure to Infuse 7 7
Air Leak 7 7
Backflow 7 7
Alarm Not Visible 6 6
Hole In Material 6 6
Component Missing 6 6
Material Separation 6 6
Appropriate Term/Code Not Available 6 6
Material Deformation 6 6
Packaging Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Increase in Pressure 5 5
Material Perforation 5 5
Unexpected Therapeutic Results 5 5
Product Quality Problem 5 5
Computer Software Problem 5 5
Corroded 5 5
Material Discolored 4 4
Fracture 4 4
Contamination 4 4
Failure to Power Up 4 4
No Audible Prompt/Feedback 4 4
Pumping Stopped 4 4
Failure to Disconnect 4 4
Biocompatibility 4 4
Incomplete or Inadequate Connection 4 4
Temperature Problem 4 4
Pumping Problem 4 4
Unintended Movement 4 4
Patient Device Interaction Problem 4 4
Device Fell 4 4
Complete Loss of Power 3 3
Audible Prompt/Feedback Problem 3 3
No Visual Prompts/Feedback 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure of Device to Self-Test 3 3
Electrical Shorting 3 3
Device Appears to Trigger Rejection 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Imprecision 3 3
Moisture Damage 3 3
Energy Output Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3233 3234
No Known Impact Or Consequence To Patient 1937 1937
No Patient Involvement 1051 1051
No Consequences Or Impact To Patient 1038 1038
Low Blood Pressure/ Hypotension 306 672
Blood Loss 299 299
Dyspnea 184 429
Death 176 420
Hypersensitivity/Allergic reaction 173 173
Cardiac Arrest 151 517
Insufficient Information 132 376
Loss of consciousness 127 615
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 102 102
Reaction 87 87
Hemolysis 78 78
Nausea 78 445
Itching Sensation 76 198
Vomiting 68 434
Hemorrhage/Bleeding 63 673
High Blood Pressure/ Hypertension 63 185
Dizziness 60 60
Chest Pain 53 53
Abdominal Pain 47 169
Chills 45 289
Low Oxygen Saturation 41 41
Headache 34 156
Fatigue 31 31
Tachycardia 31 31
Rash 30 30
Diaphoresis 28 29
Chest Tightness/Pressure 28 28
Sweating 27 149
No Code Available 27 27
Malaise 26 148
Cardiopulmonary Arrest 26 26
Weight Changes 24 24
Hypervolemia 21 143
Air Embolism 20 20
Respiratory Distress 20 20
Swelling 19 19
Hypovolemia 18 18
Exsanguination 18 140
No Information 18 18
Test Result 17 17
Anemia 17 17
Bradycardia 17 17
Pain 17 17
Edema 15 15
Fever 15 137
Shock 13 135
Respiratory Failure 13 13
Anxiety 12 12
Syncope/Fainting 12 12
Swelling/ Edema 12 12
Myocardial Infarction 12 12
Urticaria 12 134
Syncope 12 12
Cramp(s) 11 11
Weakness 11 11
Injury 11 11
Confusion/ Disorientation 11 11
Shaking/Tremors 10 10
Convulsion/Seizure 10 132
Loss Of Pulse 10 10
Peritonitis 10 10
Seizures 10 10
Muscle Weakness 9 131
Discomfort 9 9
Thrombocytopenia 8 252
Cramp(s) /Muscle Spasm(s) 8 8
Sepsis 8 130
Cyanosis 8 8
Hypoxia 8 8
Hypovolemic Shock 7 7
Erythema 7 7
Diarrhea 7 7
Palpitations 7 7
Decreased Respiratory Rate 6 6
Fungal Infection 6 6
Cough 6 6
Bruise/Contusion 6 6
Asthma 6 6
Fall 6 6
Apnea 5 127
Arrhythmia 5 5
Pneumonia 5 5
Pulmonary Edema 5 5
Hot Flashes/Flushes 5 5
Bronchospasm 5 5
Distress 5 5
Blurred Vision 5 5
Lethargy 5 5
Cognitive Changes 4 4
Numbness 4 4
Abdominal Distention 4 4
Diminished Pulse Pressure 4 4
Thrombosis/Thrombus 4 4
Tingling 4 4
Septic Shock 4 4
Anaphylactic Shock 4 4

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