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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
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 1589 4030

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3381 3626
Adverse Event Without Identified Device or Use Problem 1233 2819
Thermal Decomposition of Device 869 869
Leak/Splash 432 432
Inadequate Ultra Filtration 415 415
Melted 285 285
Break 251 251
Device Contamination with Chemical or Other Material 239 239
Device Operates Differently Than Expected 211 211
Crack 189 189
Mechanical Problem 162 162
Reflux within Device 156 156
Disconnection 136 136
Insufficient Information 122 244
Smoking 115 115
Device Displays Incorrect Message 104 104
Improper or Incorrect Procedure or Method 84 206
Charred 67 67
Device Alarm System 55 55
Patient-Device Incompatibility 43 165
Sparking 40 40
Protective Measures Problem 40 40
Obstruction of Flow 39 39
Connection Problem 36 36
Loose or Intermittent Connection 35 35
Pressure Problem 33 33
Complete Blockage 29 29
Fire 25 25
Overheating of Device 24 24
Improper Flow or Infusion 24 24
Infusion or Flow Problem 23 23
Pumping Stopped 22 22
Therapeutic or Diagnostic Output Failure 21 143
Pumping Problem 19 19
Air Leak 19 19
Coagulation in Device or Device Ingredient 18 18
Computer Software Problem 18 18
Misassembled 18 18
No Audible Alarm 17 17
Detachment Of Device Component 16 16
Contamination 15 15
Material Puncture/Hole 15 15
Detachment of Device or Device Component 15 15
Device Dislodged or Dislocated 15 137
Air/Gas in Device 15 137
Use of Device Problem 14 14
Filling Problem 14 14
Filtration Problem 13 13
No Flow 12 12
Gas Leak 11 11
No Display/Image 11 11
Defective Component 11 11
Arcing 11 11
Defective Device 10 10
Unexpected Shutdown 10 10
Hole In Material 9 9
Loss of Power 9 9
Occlusion Within Device 8 8
Material Rupture 8 130
Output Problem 8 8
Appropriate Term/Code Not Available 7 7
Material Integrity Problem 7 7
Failure to Infuse 7 7
Fracture 7 7
Backflow 7 7
Failure to Prime 6 6
Material Split, Cut or Torn 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Packaging Problem 5 5
Temperature Problem 5 5
Partial Blockage 5 5
Alarm Not Visible 5 5
Defective Alarm 5 5
Display or Visual Feedback Problem 5 5
Component Missing 5 5
Material Separation 5 5
Biocompatibility 5 5
Unexpected Therapeutic Results 4 4
Electrical Shorting 4 4
Calibration Problem 4 4
Product Quality Problem 4 4
Material Perforation 4 4
No Audible Prompt/Feedback 4 4
Material Discolored 4 4
Entrapment of Device 4 4
Material Deformation 4 4
Physical Resistance/Sticking 4 4
Incomplete or Inadequate Connection 3 3
No Visual Prompts/Feedback 3 3
Operating System Becomes Nonfunctional 3 3
Use of Incorrect Control Settings 3 3
Corroded 3 3
False Alarm 3 3
Particulates 3 3
Device Emits Odor 3 3
Nonstandard Device 3 3
Imprecision 3 3
Device Issue 3 3
Device Contamination with Body Fluid 3 3
Increase in Pressure 3 3

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 1095 1096
Blood Loss 484 484
Low Blood Pressure/ Hypotension 364 730
Death 301 545
Cardiac Arrest 198 564
Hypersensitivity/Allergic reaction 183 183
Dyspnea 169 414
Loss of consciousness 150 638
Itching Sensation 140 262
Reaction 118 118
Hemolysis 90 90
Nausea 86 453
Insufficient Information 76 320
Vomiting 70 436
High Blood Pressure/ Hypertension 52 174
Chest Pain 50 50
Chills 48 292
Cardiopulmonary Arrest 47 47
No Code Available 47 47
Dizziness 45 45
Rash 45 45
Abdominal Pain 41 163
No Information 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Chest Tightness/Pressure 37 37
Low Oxygen Saturation 34 34
Headache 33 155
Hemorrhage/Bleeding 33 643
Fatigue 33 33
Swelling 31 31
Tachycardia 30 30
Respiratory Distress 29 29
Sweating 28 150
Hypervolemia 27 149
Pain 27 27
Cramp(s) 27 27
Malaise 27 149
Weight Changes 26 26
Fever 23 145
Diaphoresis 22 23
Bradycardia 21 21
Syncope 20 20
Anemia 19 19
Exsanguination 19 141
Seizures 19 19
Anxiety 18 18
Edema 18 18
Air Embolism 17 17
Hypovolemia 17 17
Test Result 17 17
Respiratory Failure 14 14
Urticaria 14 136
Shock 13 135
Loss Of Pulse 13 13
Injury 12 12
Shaking/Tremors 11 11
Myocardial Infarction 11 11
Weakness 11 11
Tingling 10 10
Peritonitis 9 9
Hypoxia 9 9
Confusion/ Disorientation 9 9
Bruise/Contusion 8 8
Diarrhea 8 8
Stroke/CVA 7 7
Apnea 7 129
Erythema 7 7
Cyanosis 7 7
Electrolyte Imbalance 7 7
Convulsion, Tonic 7 7
Palpitations 7 7
Thrombocytopenia 7 251
Alteration In Body Temperature 6 6
Discomfort 6 6
Skin Irritation 6 6
Sepsis 6 128
Arrhythmia 6 6
Angina 5 5
Anaphylactic Shock 5 5
Dehydration 5 5
Fainting 5 5
Fall 5 5
Hypoglycemia 5 5
Thrombus 5 5
Anaphylactoid 5 5
Foreign Body In Patient 5 5
Patient Problem/Medical Problem 5 5
Lethargy 5 5
Swelling/ Edema 5 5
Bronchospasm 5 5
Numbness 4 4
Fungal Infection 4 4
Diminished Pulse Pressure 4 4
Distress 4 4
Pulmonary Edema 4 4
Unspecified Infection 4 4
Infiltration into Tissue 4 4

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc I May-03-2016
2 Baxter Healthcare Corporation II Nov-11-2021
3 Baxter Healthcare Corporation II Aug-27-2021
4 Baxter Healthcare Corporation II Mar-19-2021
5 Baxter Healthcare Corporation II Feb-26-2021
6 Baxter Healthcare Corporation II May-21-2020
7 Baxter Healthcare Corporation II Apr-30-2020
8 Baxter Healthcare Corporation II Feb-28-2020
9 Baxter Healthcare Corporation II Nov-04-2019
10 Baxter Healthcare Corporation II Oct-30-2019
11 Baxter Healthcare Corporation II Jul-01-2019
12 Baxter Healthcare Corporation II May-23-2018
13 Baxter Healthcare Corporation II Mar-30-2018
14 Baxter Healthcare Corporation II Jan-25-2017
15 Fresenius Medical Care Holdings, Inc. II Apr-20-2020
16 Fresenius Medical Care Holdings, Inc. II Mar-20-2020
17 Fresenius Medical Care Renal Therapies Group, LLC III Jun-01-2019
18 Fresenius Medical Care Renal Therapies Group, LLC II Dec-21-2018
19 Fresenius Medical Care Renal Therapies Group, LLC II Sep-19-2018
20 Fresenius Medical Care Renal Therapies Group, LLC II Mar-20-2018
21 Fresenius Medical Care Renal Therapies Group, LLC II Feb-20-2018
22 Fresenius Medical Care Renal Therapies Group, LLC II Jan-13-2017
23 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016
24 NxStage Medical, Inc. II Aug-14-2018
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