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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 4
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BELLCO SRL
  SUBSTANTIALLY EQUIVALENT 2
CHF SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
DIALCO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIALITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE REANAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 14
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 6
QUANTA DIALYSIS TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
2020 1633 1645
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 9786 9791
Adverse Event Without Identified Device or Use Problem 1127 1127
Break 696 696
Thermal Decomposition of Device 689 689
Crack 407 407
Inadequate Ultra Filtration 405 405
Device Contamination with Chemical or Other Material 294 294
Leak/Splash 205 205
Labelling, Instructions for Use or Training Problem 183 183
Melted 143 143
Air/Gas in Device 137 137
Obstruction of Flow 124 124
Detachment of Device or Device Component 121 121
Disconnection 112 112
Protective Measures Problem 95 95
Smoking 90 90
Improper or Incorrect Procedure or Method 85 85
Calibration Problem 69 69
No Apparent Adverse Event 66 66
Material Puncture/Hole 46 46
Device Alarm System 37 37
Loose or Intermittent Connection 37 37
Sparking 35 35
No Audible Alarm 34 34
Material Split, Cut or Torn 34 34
Mechanical Problem 32 32
Material Rupture 32 32
Filtration Problem 31 31
Patient-Device Incompatibility 27 27
Reflux within Device 26 26
Filling Problem 26 26
Use of Device Problem 24 24
Improper Flow or Infusion 24 24
Fire 23 23
Biocompatibility 21 21
Insufficient Device Problem Information 19 19
Infusion or Flow Problem 17 17
No Display/Image 14 14
Arcing 13 13
Fracture 13 13
Material Perforation 9 9
Connection Problem 9 9
Inaccurate Information 9 9
Complete Loss of Power 8 8
Unexpected Shutdown 8 8
Output Problem 8 8
Material Integrity Problem 7 7
Inappropriate Audible Prompt/Feedback 7 7
Coagulation in Device or Device Ingredient 6 6
Display or Visual Feedback Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7970 7977
Hemorrhage/Blood Loss/Bleeding 3656 4268
No Known Impact Or Consequence To Patient 703 709
No Consequences Or Impact To Patient 412 412
Low Blood Pressure/ Hypotension 367 733
No Patient Involvement 362 367
Hypersensitivity/Allergic reaction 327 327
Insufficient Information 271 527
Cardiac Arrest 265 631
Dyspnea 251 495
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 220 231
Loss of consciousness 127 615
Vomiting 114 480
Nausea 108 474
Blood Loss 96 96
Itching Sensation 96 218
Chest Pain 95 95
Death 89 333
Dizziness 80 80
High Blood Pressure/ Hypertension 76 198
Diaphoresis 65 65
Abdominal Pain 59 181
Low Oxygen Saturation 50 50
Discomfort 47 47
Headache 45 167
Thrombocytopenia 41 285
Swelling/ Edema 40 40
Tachycardia 39 39
Anemia 37 37
Hemolysis 36 36
Rash 33 33
Weight Changes 33 33
Malaise 31 153
Cramp(s) /Muscle Spasm(s) 31 31
Chills 29 273
Air Embolism 28 28
Syncope/Fainting 27 27
Cough 26 26
Shaking/Tremors 25 25
Bradycardia 24 24
Hypervolemia 23 145
Convulsion/Seizure 22 144
Pain 21 21
Reaction 21 21
Urticaria 20 142
Hypernatremia 19 19
Fatigue 19 19
Anxiety 18 18
Hypovolemia 17 17
Confusion/ Disorientation 17 17

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 Baxter Healthcare Corporation II May-21-2020
12 Baxter Healthcare Corporation II Apr-30-2020
13 Baxter Healthcare Corporation II Feb-28-2020
14 Fresenius Medical Care Holdings, Inc. II Jul-08-2026
15 Fresenius Medical Care Holdings, Inc. II Dec-17-2025
16 Fresenius Medical Care Holdings, Inc. II Jun-18-2025
17 Fresenius Medical Care Holdings, Inc. II Jan-03-2025
18 Fresenius Medical Care Holdings, Inc. II Sep-11-2024
19 Fresenius Medical Care Holdings, Inc. II Jul-11-2024
20 Fresenius Medical Care Holdings, Inc. II May-17-2024
21 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
22 Fresenius Medical Care Holdings, Inc. II Dec-20-2022
23 Fresenius Medical Care Holdings, Inc. II Jun-30-2022
24 Fresenius Medical Care Holdings, Inc. II Apr-20-2020
25 Fresenius Medical Care Holdings, Inc. II Mar-20-2020
26 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
27 Nipro Medical Corporation II Dec-11-2025
28 Nuwellis Inc I Jan-16-2025
29 NxStage MDS Corporation II Feb-27-2024
30 Outset Medical, Inc. II Oct-03-2024
31 Outset Medical, Inc. II Jun-14-2024
32 Outset Medical, Inc. I Apr-12-2024
33 Outset Medical, Inc. II Mar-21-2022
34 VANTIVE US HEALTHCARE LLC II Feb-02-2026
35 VANTIVE US HEALTHCARE LLC II Aug-26-2025
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