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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 9
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
QUANTA DIALYSIS TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
QUANTA DIALYSIS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECNOIDEAL AMERICA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1633 1633
2021 1944 4385
2022 2180 2180
2023 2708 2708
2024 2446 2446
2025 722 722

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7740 7985
Adverse Event Without Identified Device or Use Problem 1038 2624
Thermal Decomposition of Device 584 584
Break 496 496
Inadequate Ultra Filtration 315 315
Crack 313 313
Device Contamination with Chemical or Other Material 243 243
Leak/Splash 224 224
Melted 136 136
Disconnection 111 111
Air/Gas in Device 108 230
Obstruction of Flow 97 97
Improper or Incorrect Procedure or Method 90 212
Smoking 82 82
Protective Measures Problem 82 82
Calibration Problem 66 66
No Apparent Adverse Event 62 62
Detachment of Device or Device Component 58 58
Device Alarm System 52 52
Material Puncture/Hole 45 45
Loose or Intermittent Connection 41 41
Improper Flow or Infusion 38 38
Therapeutic or Diagnostic Output Failure 34 156
Sparking 33 33
Mechanical Problem 32 32
Filtration Problem 30 30
Device Displays Incorrect Message 29 29
No Audible Alarm 29 29
Material Split, Cut or Torn 29 29
Unexpected Shutdown 27 27
Fire 26 26
Reflux within Device 25 25
Pressure Problem 23 23
Insufficient Information 23 145
Filling Problem 19 19
Infusion or Flow Problem 19 19
Defective Device 19 19
Patient-Device Incompatibility 18 140
Material Rupture 18 140
Display or Visual Feedback Problem 17 17
Use of Device Problem 17 17
No Display/Image 16 16
Product Quality Problem 16 16
Biocompatibility 15 15
Defective Component 15 15
Output Problem 15 15
Connection Problem 15 15
Device Dislodged or Dislocated 12 134
Defective Alarm 12 12
No Flow 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6078 6079
Hemorrhage/Bleeding 2505 3115
No Known Impact Or Consequence To Patient 703 703
No Consequences Or Impact To Patient 412 412
No Patient Involvement 362 362
Low Blood Pressure/ Hypotension 309 675
Hypersensitivity/Allergic reaction 239 239
Insufficient Information 228 472
Cardiac Arrest 211 577
Dyspnea 196 440
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 175 175
Loss of consciousness 113 601
Blood Loss 96 96
Death 89 333
Vomiting 87 453
Nausea 81 447
Chest Pain 79 79
Itching Sensation 74 196
High Blood Pressure/ Hypertension 66 188
Dizziness 64 64
Abdominal Pain 53 175
Diaphoresis 47 47
Headache 42 164
Discomfort 41 41
Thrombocytopenia 35 279
Low Oxygen Saturation 33 33
Tachycardia 33 33
Swelling/ Edema 31 31
Hemolysis 30 30
Weight Changes 29 29
Malaise 28 150
Cramp(s) /Muscle Spasm(s) 26 26
Anemia 26 26
Rash 25 25
Air Embolism 25 25
Syncope/Fainting 24 24
Shaking/Tremors 23 23
Cough 21 21
Hypervolemia 21 143
Reaction 21 21
Pain 20 20
Convulsion/Seizure 19 141
Chills 19 263
Bradycardia 19 19
Hypernatremia 19 19
Hypovolemia 16 16
Fatigue 15 15
Confusion/ Disorientation 14 14
Urticaria 13 135
Anxiety 13 13

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 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 Fresenius Medical Care Holdings, Inc. II Apr-20-2020
22 Fresenius Medical Care Holdings, Inc. II Mar-20-2020
23 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
24 Nuwellis Inc I Jan-16-2025
25 NxStage MDS Corporation II Feb-27-2024
26 Outset Medical, Inc. II Oct-03-2024
27 Outset Medical, Inc. II Jun-14-2024
28 Outset Medical, Inc. I Apr-12-2024
29 Outset Medical, Inc. II Mar-21-2022
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