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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
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BELLCO SRL
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
DIALITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 12
MEDICA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
QUANTA DIALYSIS TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TECNOIDEAL AMERICA
  SUBSTANTIALLY EQUIVALENT 1
VANTIVE US HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1944 4392
2022 2180 2207
2023 2692 2695
2024 2441 2443
2025 2822 2822
2026 1266 1266

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8926 8931
Adverse Event Without Identified Device or Use Problem 963 963
Break 647 647
Thermal Decomposition of Device 596 596
Crack 370 370
Inadequate Ultra Filtration 345 345
Device Contamination with Chemical or Other Material 227 227
Labelling, Instructions for Use or Training Problem 183 183
Leak/Splash 138 138
Air/Gas in Device 137 137
Obstruction of Flow 121 121
Detachment of Device or Device Component 121 121
Melted 107 107
Protective Measures Problem 89 89
Disconnection 86 86
Smoking 79 79
Calibration Problem 69 69
No Apparent Adverse Event 66 66
Improper or Incorrect Procedure or Method 56 56
Material Puncture/Hole 45 45
Loose or Intermittent Connection 34 34
Material Split, Cut or Torn 33 33
Device Alarm System 32 32
Filtration Problem 30 30
Material Rupture 29 29
Sparking 28 28
No Audible Alarm 27 27
Patient-Device Incompatibility 26 26
Mechanical Problem 26 26
Use of Device Problem 24 24
Filling Problem 24 24
Improper Flow or Infusion 23 23
Reflux within Device 21 21
Fire 20 20
Biocompatibility 20 20
Insufficient Device Problem Information 18 18
Infusion or Flow Problem 17 17
Fracture 13 13
No Display/Image 12 12
Arcing 10 10
Inaccurate Information 9 9
Connection Problem 9 9
Output Problem 8 8
Complete Loss of Power 8 8
Unexpected Shutdown 8 8
Material Integrity Problem 7 7
Material Perforation 7 7
Inappropriate Audible Prompt/Feedback 7 7
Display or Visual Feedback Problem 6 6
Use of Incorrect Control/Treatment Settings 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7948 7955
Hemorrhage/Blood Loss/Bleeding 3654 4266
Low Blood Pressure/ Hypotension 307 673
Hypersensitivity/Allergic reaction 305 305
Insufficient Information 258 514
Cardiac Arrest 240 606
Dyspnea 218 462
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 218 228
Vomiting 102 468
Loss of consciousness 102 590
Nausea 98 464
Chest Pain 88 88
Itching Sensation 83 205
No Consequences Or Impact To Patient 74 74
Dizziness 70 70
No Known Impact Or Consequence To Patient 63 63
High Blood Pressure/ Hypertension 61 183
Diaphoresis 59 59
No Patient Involvement 57 57
Discomfort 46 46
Low Oxygen Saturation 43 43
Thrombocytopenia 41 285
Abdominal Pain 41 163
Swelling/ Edema 39 39
Anemia 36 36
Tachycardia 36 36
Headache 35 157
Cramp(s) /Muscle Spasm(s) 31 31
Hemolysis 30 30
Weight Changes 29 29
Chills 28 272
Rash 28 28
Cough 26 26
Syncope/Fainting 26 26
Air Embolism 24 24
Convulsion/Seizure 22 144
Shaking/Tremors 21 21
Bradycardia 21 21
Hypervolemia 20 142
Malaise 20 142
Urticaria 19 141
Death 18 262
Fatigue 18 18
Hypernatremia 17 17
Blood Loss 16 16
Pain 16 16
Confusion/ Disorientation 15 15
Hypovolemia 15 15
Hot Flashes/Flushes 14 14
Fever 14 136

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Apr-15-2022
2 Baxter Healthcare Corporation I Nov-13-2024
3 Baxter Healthcare Corporation II Dec-22-2022
4 Baxter Healthcare Corporation II Dec-22-2022
5 Baxter Healthcare Corporation II Oct-12-2022
6 Baxter Healthcare Corporation II Apr-22-2022
7 Baxter Healthcare Corporation II Nov-11-2021
8 Baxter Healthcare Corporation II Aug-27-2021
9 Baxter Healthcare Corporation II Mar-19-2021
10 Baxter Healthcare Corporation II Feb-26-2021
11 Fresenius Medical Care Holdings, Inc. II Jul-08-2026
12 Fresenius Medical Care Holdings, Inc. II Dec-17-2025
13 Fresenius Medical Care Holdings, Inc. II Jun-18-2025
14 Fresenius Medical Care Holdings, Inc. II Jan-03-2025
15 Fresenius Medical Care Holdings, Inc. II Sep-11-2024
16 Fresenius Medical Care Holdings, Inc. II Jul-11-2024
17 Fresenius Medical Care Holdings, Inc. II May-17-2024
18 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
19 Fresenius Medical Care Holdings, Inc. II Dec-20-2022
20 Fresenius Medical Care Holdings, Inc. II Jun-30-2022
21 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
22 Nipro Medical Corporation II Dec-11-2025
23 Nuwellis Inc I Jan-16-2025
24 NxStage MDS Corporation II Feb-27-2024
25 Outset Medical, Inc. II Oct-03-2024
26 Outset Medical, Inc. II Jun-14-2024
27 Outset Medical, Inc. I Apr-12-2024
28 Outset Medical, Inc. II Mar-21-2022
29 VANTIVE US HEALTHCARE LLC II Feb-02-2026
30 VANTIVE US HEALTHCARE LLC II Aug-26-2025
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