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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 11
MEDICA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 2617 2617

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8953 9204
Adverse Event Without Identified Device or Use Problem 1152 2738
Thermal Decomposition of Device 644 644
Break 636 636
Inadequate Ultra Filtration 355 355
Crack 354 354
Device Contamination with Chemical or Other Material 274 274
Leak/Splash 234 240
Labelling, Instructions for Use or Training Problem 177 177
Melted 138 138
Air/Gas in Device 137 269
Disconnection 118 118
Obstruction of Flow 118 126
Protective Measures Problem 97 97
Improper or Incorrect Procedure or Method 96 218
Detachment of Device or Device Component 95 95
Smoking 86 86
Calibration Problem 69 69
No Apparent Adverse Event 63 63
Device Alarm System 55 56
Material Puncture/Hole 52 52
Loose or Intermittent Connection 44 54
Therapeutic or Diagnostic Output Failure 40 169
Improper Flow or Infusion 39 39
Mechanical Problem 38 38
Sparking 35 35
Filtration Problem 35 35
No Audible Alarm 32 32
Material Split, Cut or Torn 32 32
Use of Device Problem 29 29
Device Displays Incorrect Message 29 31
Patient-Device Incompatibility 29 151
Unexpected Shutdown 28 29
Fire 27 27
Material Rupture 26 148
Reflux within Device 26 26
Pressure Problem 25 35
Output Problem 24 24
Insufficient Information 24 146
Infusion or Flow Problem 23 23
Defective Device 23 24
Filling Problem 22 22
Biocompatibility 21 21
Connection Problem 20 20
No Display/Image 19 20
Display or Visual Feedback Problem 18 18
Product Quality Problem 17 34
Defective Component 16 28
Priming Problem 13 13
Failure to Prime 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7118 7125
Hemorrhage/Bleeding 3165 3777
No Known Impact Or Consequence To Patient 703 709
No Consequences Or Impact To Patient 412 412
No Patient Involvement 362 367
Low Blood Pressure/ Hypotension 348 714
Hypersensitivity/Allergic reaction 305 305
Insufficient Information 253 509
Dyspnea 236 480
Cardiac Arrest 230 596
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 196 207
Loss of consciousness 119 607
Vomiting 105 471
Nausea 98 464
Blood Loss 96 96
Chest Pain 90 90
Death 89 333
Itching Sensation 86 208
Dizziness 76 76
High Blood Pressure/ Hypertension 71 193
Diaphoresis 59 59
Abdominal Pain 53 175
Low Oxygen Saturation 48 48
Headache 45 167
Discomfort 44 44
Tachycardia 37 37
Anemia 36 36
Thrombocytopenia 36 280
Swelling/ Edema 35 35
Hemolysis 32 32
Rash 32 32
Weight Changes 31 31
Malaise 31 153
Cramp(s) /Muscle Spasm(s) 29 29
Air Embolism 27 27
Chills 26 270
Syncope/Fainting 25 25
Cough 24 24
Shaking/Tremors 24 24
Hypervolemia 22 144
Bradycardia 22 22
Pain 21 21
Reaction 21 21
Convulsion/Seizure 20 142
Fatigue 19 19
Hypernatremia 19 19
Urticaria 18 140
Anxiety 18 18
Confusion/ Disorientation 17 17
Hypovolemia 16 16

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