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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 1693 1693

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7427 7672
Adverse Event Without Identified Device or Use Problem 1190 2776
Thermal Decomposition of Device 695 695
Break 477 477
Inadequate Ultra Filtration 338 338
Crack 301 301
Device Contamination with Chemical or Other Material 294 294
Leak/Splash 282 282
Melted 203 203
Disconnection 127 127
Improper or Incorrect Procedure or Method 99 221
Smoking 99 99
Obstruction of Flow 98 98
Air/Gas in Device 96 218
Protective Measures Problem 83 83
Device Displays Incorrect Message 62 62
No Apparent Adverse Event 57 57
Device Alarm System 56 56
Detachment of Device or Device Component 54 54
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
Reflux within Device 26 26
Insufficient Information 25 147
Material Split, Cut or Torn 25 25
Pressure Problem 23 23
Infusion or Flow Problem 21 21
Defective Device 20 20
Material Rupture 18 140
Use of Device Problem 18 18
Display or Visual Feedback Problem 17 17
Output Problem 16 16
No Display/Image 16 16
Product Quality Problem 16 16
Gas/Air Leak 15 15
Complete Blockage 15 15
Filling Problem 15 15
Defective Component 14 14
Calibration Problem 14 14
Connection Problem 14 14
No Flow 13 13
Arcing 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5467 5468
Hemorrhage/Bleeding 1821 2431
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 357 723
Dyspnea 234 479
Hypersensitivity/Allergic reaction 232 232
Insufficient Information 209 453
Cardiac Arrest 200 566
Blood Loss 162 162
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 160 160
Loss of consciousness 129 617
Death 128 372
Nausea 95 462
Itching Sensation 92 214
Chest Pain 81 81
Dizziness 80 80
Vomiting 78 444
Hemolysis 76 76
High Blood Pressure/ Hypertension 71 193
Abdominal Pain 59 181
Diaphoresis 47 48
Low Oxygen Saturation 39 39
Discomfort 38 38
Headache 37 159
Tachycardia 37 37
Malaise 35 157
Reaction 33 33
Anemia 28 28
Weight Changes 27 27
Rash 27 27
Swelling/ Edema 26 26
Sweating 24 146
Pain 23 23
Chest Tightness/Pressure 23 23
Syncope/Fainting 23 23
Chills 23 267
Hypervolemia 23 145
No Code Available 23 23
Air Embolism 23 23
Bradycardia 20 20
Urticaria 20 142
Hypovolemia 19 19
Convulsion/Seizure 18 140
Cramp(s) /Muscle Spasm(s) 18 18
Cough 18 18
Fatigue 17 17
Hypernatremia 17 17
Test Result 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 Jun-14-2024
28 Outset Medical, Inc. I Apr-12-2024
29 Outset Medical, Inc. II Mar-21-2022
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