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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 5
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 REANAL THERAPIES GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 6
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 2182 2182
2023 1836 1836

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6144 6389
Adverse Event Without Identified Device or Use Problem 1200 2786
Thermal Decomposition of Device 905 905
Inadequate Ultra Filtration 428 428
Break 405 405
Leak/Splash 358 358
Device Contamination with Chemical or Other Material 306 306
Melted 274 274
Crack 254 254
Disconnection 142 142
Smoking 113 113
Improper or Incorrect Procedure or Method 105 227
Device Displays Incorrect Message 88 88
Air/Gas in Device 80 202
Protective Measures Problem 72 72
Obstruction of Flow 64 64
Device Alarm System 59 59
Improper Flow or Infusion 47 47
Loose or Intermittent Connection 45 45
Sparking 43 43
Patient-Device Incompatibility 43 165
Mechanical Problem 38 38
Therapeutic or Diagnostic Output Failure 37 159
Detachment of Device or Device Component 36 36
Device Operates Differently Than Expected 36 36
Material Puncture/Hole 31 31
Insufficient Information 31 153
Filtration Problem 29 29
Reflux within Device 27 27
Fire 26 26
Unexpected Shutdown 25 25
Pressure Problem 24 24
No Audible Alarm 24 24
Charred 24 24
Infusion or Flow Problem 23 23
No Apparent Adverse Event 20 20
Material Split, Cut or Torn 20 20
Defective Device 20 20
Misassembled 18 18
Complete Blockage 17 17
Material Rupture 17 139
No Flow 17 17
Output Problem 16 16
Gas/Air Leak 16 16
Filling Problem 16 16
Product Quality Problem 16 16
No Display/Image 15 15
Display or Visual Feedback Problem 15 15
Defective Component 15 15
Calibration Problem 15 15
Device Dislodged or Dislocated 14 136
Arcing 14 14
Use of Device Problem 14 14
Defective Alarm 14 14
Connection Problem 13 13
Overheating of Device 11 11
Failure to Prime 10 10
Backflow 10 10
Computer Software Problem 9 9
Material Integrity Problem 9 9
Physical Resistance/Sticking 9 9
Inaccurate Information 9 9
Loss of Power 8 8
Increase in Pressure 7 7
Coagulation in Device or Device Ingredient 7 7
Alarm Not Visible 7 7
Air Leak 7 7
Material Separation 7 7
Failure to Infuse 7 7
Priming Problem 7 7
Patient Device Interaction Problem 7 7
Material Twisted/Bent 7 7
Packaging Problem 6 6
Material Deformation 6 6
Appropriate Term/Code Not Available 6 6
Component Missing 6 6
Biocompatibility 6 6
Use of Incorrect Control/Treatment Settings 6 6
Fracture 6 6
Hole In Material 6 6
Corroded 5 5
Device Sensing Problem 5 5
Unexpected Therapeutic Results 5 5
Material Perforation 5 5
Temperature Problem 5 5
Complete Loss of Power 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Incomplete or Inadequate Connection 4 4
Audible Prompt/Feedback Problem 4 4
Unintended Movement 4 4
Pumping Problem 4 4
Device Fell 4 4
Device Appears to Trigger Rejection 4 4
Failure of Device to Self-Test 4 4
Electrical Shorting 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Failure to Disconnect 4 4
No Audible Prompt/Feedback 4 4
Material Discolored 4 4
Contamination 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4471 4472
No Known Impact Or Consequence To Patient 1937 1937
No Patient Involvement 1051 1051
No Consequences Or Impact To Patient 1038 1038
Hemorrhage/Bleeding 493 1103
Low Blood Pressure/ Hypotension 357 723
Blood Loss 300 300
Dyspnea 209 454
Hypersensitivity/Allergic reaction 205 205
Cardiac Arrest 186 552
Death 176 420
Insufficient Information 175 419
Loss of consciousness 139 627
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 130 130
Reaction 87 87
Nausea 87 454
Itching Sensation 85 207
Hemolysis 82 82
Vomiting 73 439
Dizziness 70 70
High Blood Pressure/ Hypertension 66 188
Chest Pain 64 64
Abdominal Pain 52 174
Chills 46 290
Low Oxygen Saturation 44 44
Diaphoresis 37 38
Headache 36 158
Fatigue 34 34
Tachycardia 33 33
Rash 31 31
Malaise 31 153
Discomfort 30 30
Chest Tightness/Pressure 28 28
Sweating 27 149
No Code Available 27 27
Air Embolism 26 26
Cardiopulmonary Arrest 26 26
Weight Changes 25 25
Hypervolemia 22 144
Anemia 22 22
Hypovolemia 21 21
Respiratory Distress 20 20
Pain 19 19
Swelling 19 19
Exsanguination 19 141
Bradycardia 18 18
No Information 18 18
Test Result 17 17
Respiratory Failure 16 16
Urticaria 16 138
Fever 16 138
Hypernatremia 16 16
Edema 15 15
Swelling/ Edema 15 15
Anxiety 14 14
Myocardial Infarction 14 14
Shock 13 135
Convulsion/Seizure 13 135
Syncope/Fainting 13 13
Confusion/ Disorientation 12 12
Syncope 12 12
Muscle Weakness 11 133
Cramp(s) 11 11
Weakness 11 11
Injury 11 11
Cramp(s) /Muscle Spasm(s) 11 11
Shaking/Tremors 10 10
Loss Of Pulse 10 10
Peritonitis 10 10
Seizures 10 10
Hypoxia 10 10
Thrombocytopenia 9 253
Cough 9 9
Cyanosis 8 8
Sepsis 8 130
Diarrhea 7 7
Asthma 7 7
Hypovolemic Shock 7 7
Erythema 7 7
Fall 7 7
Decreased Respiratory Rate 7 7
Palpitations 7 7
Fungal Infection 6 6
Lethargy 6 6
Bruise/Contusion 6 6
Apnea 6 128
Local Reaction 6 6
Pneumonia 6 6
Pulmonary Edema 6 6
Blurred Vision 6 6
Hot Flashes/Flushes 5 5
Septic Shock 5 5
Arrhythmia 5 5
Stroke/CVA 5 5
Bronchospasm 5 5
Abdominal Distention 5 5
Respiratory Arrest 5 127
Thrombosis/Thrombus 5 5
Numbness 5 5
Distress 5 5

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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