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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 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 7
NEPHROS
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
2019 1587 1587
2020 1633 1633
2021 1944 4385
2022 2180 2180
2023 2708 2708
2024 1893 1893

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7573 7818
Adverse Event Without Identified Device or Use Problem 1207 2793
Thermal Decomposition of Device 708 708
Break 487 487
Inadequate Ultra Filtration 341 341
Crack 304 304
Device Contamination with Chemical or Other Material 296 296
Leak/Splash 282 282
Melted 207 207
Disconnection 127 127
Smoking 100 100
Improper or Incorrect Procedure or Method 99 221
Obstruction of Flow 99 99
Air/Gas in Device 97 219
Protective Measures Problem 84 84
Device Displays Incorrect Message 62 62
No Apparent Adverse Event 57 57
Detachment of Device or Device Component 56 56
Device Alarm System 56 56
Improper Flow or Infusion 46 46
Loose or Intermittent Connection 43 43
Material Puncture/Hole 42 42
Therapeutic or Diagnostic Output Failure 37 159
Mechanical Problem 35 35
Sparking 35 35
Patient-Device Incompatibility 32 154
Filtration Problem 31 31
Fire 29 29
No Audible Alarm 28 28
Unexpected Shutdown 27 27
Material Split, Cut or Torn 26 26
Reflux within Device 26 26
Insufficient Information 25 147
Pressure Problem 23 23
Infusion or Flow Problem 21 21
Defective Device 20 20
Use of Device Problem 18 18
Material Rupture 18 140
Display or Visual Feedback Problem 17 17
No Display/Image 16 16
Product Quality Problem 16 16
Output Problem 16 16
Filling Problem 15 15
Complete Blockage 15 15
Defective Component 15 15
Gas/Air Leak 15 15
Connection Problem 15 15
Calibration Problem 14 14
Arcing 13 13
No Flow 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5526 5527
Hemorrhage/Bleeding 1938 2548
No Known Impact Or Consequence To Patient 1237 1237
No Consequences Or Impact To Patient 811 811
No Patient Involvement 643 643
Low Blood Pressure/ Hypotension 364 730
Hypersensitivity/Allergic reaction 237 237
Dyspnea 235 480
Insufficient Information 211 455
Cardiac Arrest 205 571
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 162 162
Blood Loss 162 162
Loss of consciousness 131 619
Death 128 372
Nausea 95 462
Itching Sensation 94 216
Chest Pain 83 83
Dizziness 81 81
Vomiting 78 444
Hemolysis 78 78
High Blood Pressure/ Hypertension 73 195
Abdominal Pain 63 185
Diaphoresis 48 49
Tachycardia 39 39
Low Oxygen Saturation 39 39
Discomfort 38 38
Headache 37 159
Malaise 35 157
Reaction 33 33
Rash 28 28
Anemia 28 28
Weight Changes 28 28
Swelling/ Edema 26 26
Sweating 24 146
Pain 24 24
Hypervolemia 24 146
Chills 23 267
No Code Available 23 23
Chest Tightness/Pressure 23 23
Syncope/Fainting 23 23
Air Embolism 23 23
Bradycardia 21 21
Cough 21 21
Urticaria 20 142
Hypovolemia 19 19
Cramp(s) /Muscle Spasm(s) 18 18
Hypernatremia 18 18
Convulsion/Seizure 18 140
Fatigue 17 17
Anxiety 15 15

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 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 Fresenius Medical Care Renal Therapies Group, LLC III Jun-01-2019
25 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
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
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