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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 1
BAXTER HEALTHCARE CORP
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1939 4380

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3583 3828
Adverse Event Without Identified Device or Use Problem 1117 2703
Thermal Decomposition of Device 803 803
Inadequate Ultra Filtration 397 397
Leak/Splash 385 385
Break 261 261
Melted 249 249
Device Contamination with Chemical or Other Material 244 244
Crack 182 182
Disconnection 126 126
Smoking 102 102
Device Displays Incorrect Message 95 95
Improper or Incorrect Procedure or Method 83 205
Device Operates Differently Than Expected 74 74
Charred 51 51
Mechanical Problem 46 46
Protective Measures Problem 44 44
Obstruction of Flow 43 43
Patient-Device Incompatibility 41 163
Reflux within Device 41 41
Sparking 40 40
Insufficient Information 38 160
Loose or Intermittent Connection 35 35
Device Alarm System 34 34
Pressure Problem 31 31
Improper Flow or Infusion 25 25
Therapeutic or Diagnostic Output Failure 23 145
Fire 21 21
Infusion or Flow Problem 20 20
Connection Problem 19 19
Misassembled 18 18
Material Puncture/Hole 17 17
Complete Blockage 17 17
No Audible Alarm 16 16
Detachment of Device or Device Component 16 16
Air/Gas in Device 16 138
Pumping Problem 15 15
Detachment Of Device Component 14 14
Filling Problem 13 13
Pumping Stopped 13 13
Filtration Problem 13 13
Gas Leak 12 12
Air Leak 12 12
Overheating of Device 11 11
Arcing 11 11
Defective Device 11 11
Use of Device Problem 11 11
Defective Component 10 10
No Flow 10 10
Unexpected Shutdown 10 10
Output Problem 9 9
Loss of Power 9 9
Hole In Material 9 9
No Display/Image 9 9
Material Rupture 8 130
Device Dislodged or Dislocated 8 130
Material Split, Cut or Torn 8 8
Material Integrity Problem 7 7
Failure to Infuse 7 7
Fracture 7 7
Display or Visual Feedback Problem 6 6
Defective Alarm 6 6
Backflow 6 6
Coagulation in Device or Device Ingredient 6 6
Failure to Prime 6 6
Appropriate Term/Code Not Available 6 6
Packaging Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Product Quality Problem 5 5
Partial Blockage 5 5
Alarm Not Visible 5 5
Material Separation 5 5
Material Deformation 5 5
Biocompatibility 4 4
Material Perforation 4 4
No Audible Prompt/Feedback 4 4
Component Missing 4 4
Computer Software Problem 4 4
Material Discolored 4 4
Physical Resistance/Sticking 4 4
Incomplete or Inadequate Connection 3 3
No Visual Prompts/Feedback 3 3
Temperature Problem 3 3
Imprecision 3 3
Occlusion Within Device 3 3
Contamination 3 3
Use of Incorrect Control Settings 3 3
Corroded 3 3
Entrapment of Device 3 3
False Alarm 3 3
Cut In Material 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Unexpected Therapeutic Results 3 3
Calibration Problem 3 3
Communication or Transmission Problem 3 3
Electrical Shorting 3 3
Device Sensing Problem 2 2
Failure of Device to Self-Test 2 2
No Fail-Safe Mechanism 2 2
Manufacturing, Packaging or Shipping Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2251 2251
No Clinical Signs, Symptoms or Conditions 1384 1385
No Patient Involvement 1233 1233
No Consequences Or Impact To Patient 1164 1164
Blood Loss 379 379
Low Blood Pressure/ Hypotension 328 694
Death 226 470
Dyspnea 167 412
Cardiac Arrest 149 515
Hypersensitivity/Allergic reaction 144 144
Itching Sensation 139 261
Loss of consciousness 136 624
Reaction 109 109
Nausea 85 452
Hemolysis 82 82
Insufficient Information 82 326
Vomiting 67 433
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 52 52
Dizziness 51 51
High Blood Pressure/ Hypertension 51 173
Chills 46 290
Chest Pain 45 45
Abdominal Pain 43 165
Rash 43 43
No Code Available 38 38
Cardiopulmonary Arrest 35 35
Fatigue 33 33
Headache 33 155
Chest Tightness/Pressure 33 33
Hemorrhage/Bleeding 32 642
Low Oxygen Saturation 31 31
Swelling 29 29
Respiratory Distress 28 28
Sweating 28 150
No Information 28 28
Tachycardia 26 26
Malaise 25 147
Diaphoresis 25 26
Weight Changes 23 23
Hypervolemia 22 144
Cramp(s) 21 21
Exsanguination 19 141
Edema 18 18
Anxiety 17 17
Hypovolemia 17 17
Pain 17 17
Test Result 17 17
Air Embolism 16 16
Bradycardia 16 16
Anemia 15 15
Respiratory Failure 14 14
Syncope 13 13
Seizures 13 13
Shock 13 135
Urticaria 12 134
Injury 12 12
Weakness 11 11
Fever 11 133
Loss Of Pulse 11 11
Shaking/Tremors 10 10
Myocardial Infarction 10 10
Tingling 9 9
Peritonitis 9 9
Confusion/ Disorientation 9 9
Thrombocytopenia 8 252
Hypoxia 8 8
Bruise/Contusion 8 8
Diarrhea 8 8
Cyanosis 7 7
Discomfort 7 7
Convulsion, Tonic 7 7
Palpitations 7 7
Alteration In Body Temperature 6 6
Swelling/ Edema 6 6
Skin Irritation 6 6
Erythema 6 6
Fall 6 6
Stroke/CVA 6 6
Apnea 6 128
Arrhythmia 5 5
Sepsis 5 127
Electrolyte Imbalance 5 5
Cough 5 5
Lethargy 5 5
Bronchospasm 5 5
Abdominal Distention 4 4
Diminished Pulse Pressure 4 4
Numbness 4 4
Fungal Infection 4 4
Foreign Body In Patient 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Distress 4 4
Muscle Weakness 4 126
Pulmonary Edema 4 4
Asthma 4 4
Congestive Heart Failure 4 4
Anaphylactic Shock 4 4
Hypoglycemia 4 4
Unspecified Infection 4 4
Fainting 3 3

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