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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 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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7276 7521
Adverse Event Without Identified Device or Use Problem 972 2558
Thermal Decomposition of Device 554 554
Break 458 458
Inadequate Ultra Filtration 304 304
Crack 297 297
Device Contamination with Chemical or Other Material 238 238
Leak/Splash 223 223
Melted 134 134
Disconnection 108 108
Air/Gas in Device 101 223
Obstruction of Flow 90 90
Improper or Incorrect Procedure or Method 88 210
Smoking 81 81
Protective Measures Problem 79 79
No Apparent Adverse Event 58 58
Detachment of Device or Device Component 54 54
Device Alarm System 52 52
Material Puncture/Hole 44 44
Loose or Intermittent Connection 40 40
Improper Flow or Infusion 38 38
Therapeutic or Diagnostic Output Failure 34 156
Sparking 32 32
Mechanical Problem 31 31
Filtration Problem 30 30
Material Split, Cut or Torn 29 29
Device Displays Incorrect Message 29 29
No Audible Alarm 28 28
Unexpected Shutdown 27 27
Fire 26 26
Reflux within Device 24 24
Pressure Problem 23 23
Insufficient Information 22 144
Infusion or Flow Problem 19 19
Defective Device 19 19
Material Rupture 18 140
Patient-Device Incompatibility 18 140
Use of Device Problem 17 17
Display or Visual Feedback Problem 17 17
No Display/Image 16 16
Product Quality Problem 16 16
Output Problem 15 15
Calibration Problem 14 14
Connection Problem 14 14
Defective Component 14 14
Biocompatibility 13 13
Filling Problem 13 13
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 5761 5762
Hemorrhage/Bleeding 2196 2806
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 300 666
Insufficient Information 220 464
Hypersensitivity/Allergic reaction 217 217
Cardiac Arrest 200 566
Dyspnea 191 435
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 171 171
Loss of consciousness 109 597
Blood Loss 96 96
Death 89 333
Chest Pain 76 76
Itching Sensation 70 192
Vomiting 64 430
Nausea 64 430
Dizziness 63 63
High Blood Pressure/ Hypertension 62 184
Abdominal Pain 52 174
Diaphoresis 45 45
Discomfort 40 40
Low Oxygen Saturation 32 32
Tachycardia 32 32
Swelling/ Edema 29 29
Weight Changes 28 28
Malaise 28 150
Hemolysis 28 28
Headache 26 148
Rash 25 25
Anemia 25 25
Syncope/Fainting 24 24
Air Embolism 22 22
Reaction 21 21
Cough 21 21
Cramp(s) /Muscle Spasm(s) 20 20
Hypervolemia 19 141
Bradycardia 19 19
Hypernatremia 19 19
Pain 19 19
Chills 18 262
Convulsion/Seizure 18 140
Hypovolemia 16 16
Fatigue 13 13
Urticaria 13 135
Confusion/ Disorientation 13 13
Anxiety 13 13
Hypoxia 12 12
Muscle Weakness 12 134

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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