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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
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 1274 1274

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7122 7367
Adverse Event Without Identified Device or Use Problem 1151 2737
Thermal Decomposition of Device 677 677
Break 463 463
Inadequate Ultra Filtration 327 327
Crack 292 292
Device Contamination with Chemical or Other Material 286 286
Leak/Splash 282 282
Melted 202 202
Disconnection 126 126
Smoking 99 99
Improper or Incorrect Procedure or Method 98 220
Obstruction of Flow 98 98
Air/Gas in Device 96 218
Protective Measures Problem 80 80
Device Displays Incorrect Message 62 62
Device Alarm System 56 56
No Apparent Adverse Event 53 53
Detachment of Device or Device Component 52 52
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 30 30
Fire 28 28
Reflux within Device 26 26
No Audible Alarm 26 26
Unexpected Shutdown 26 26
Material Split, Cut or Torn 24 24
Insufficient Information 24 146
Pressure Problem 23 23
Infusion or Flow Problem 21 21
Defective Device 20 20
Material Rupture 18 140
Use of Device Problem 17 17
Product Quality Problem 16 16
Display or Visual Feedback Problem 16 16
Output Problem 16 16
No Display/Image 15 15
Complete Blockage 15 15
Gas/Air Leak 15 15
Calibration Problem 14 14
Defective Component 14 14
Arcing 13 13
Connection Problem 13 13
No Flow 13 13
Device Dislodged or Dislocated 12 134
Filling Problem 12 12
Defective Alarm 11 11
Failure to Prime 10 10
Backflow 9 9
Physical Resistance/Sticking 9 9
Patient Device Interaction Problem 9 9
Inaccurate Information 9 9
Computer Software Problem 8 8
Material Integrity Problem 8 8
Material Separation 8 8
Component Missing 7 7
Material Twisted/Bent 7 7
Coagulation in Device or Device Ingredient 7 7
Increase in Pressure 7 7
Priming Problem 7 7
Appropriate Term/Code Not Available 6 6
Loss of Power 6 6
Use of Incorrect Control/Treatment Settings 6 6
Fracture 6 6
Contamination 5 5
Overheating of Device 5 5
Material Deformation 5 5
Device Sensing Problem 5 5
Biocompatibility 5 5
Failure to Disconnect 5 5
Unexpected Therapeutic Results 5 5
Material Perforation 5 5
Packaging Problem 5 5
Complete Loss of Power 5 5
Incomplete or Inadequate Connection 4 4
Device Fell 4 4
Audible Prompt/Feedback Problem 4 4
Failure of Device to Self-Test 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Failure to Power Up 4 4
Device Appears to Trigger Rejection 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Energy Output Problem 3 3
Moisture Damage 3 3
Device Emits Odor 3 3
Imprecision 3 3
Misassembled 3 3
Alarm Not Visible 3 3
False Alarm 3 3
Electrical Shorting 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Pumping Stopped 3 3
Device Tipped Over 3 3
Inadequate Filtration Process 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5335 5336
Hemorrhage/Bleeding 1587 2197
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 343 709
Dyspnea 219 464
Hypersensitivity/Allergic reaction 218 218
Insufficient Information 206 450
Cardiac Arrest 192 558
Blood Loss 162 162
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 152 152
Death 128 372
Loss of consciousness 127 615
Nausea 93 460
Itching Sensation 87 209
Dizziness 78 78
Chest Pain 77 77
Hemolysis 76 76
Vomiting 76 442
High Blood Pressure/ Hypertension 67 189
Abdominal Pain 58 180
Diaphoresis 45 46
Low Oxygen Saturation 39 39
Headache 37 159
Malaise 35 157
Tachycardia 35 35
Reaction 33 33
Discomfort 33 33
Rash 27 27
Anemia 27 27
Swelling/ Edema 25 25
Sweating 24 146
Chest Tightness/Pressure 23 23
Weight Changes 23 23
No Code Available 23 23
Air Embolism 23 23
Pain 23 23
Chills 22 266
Syncope/Fainting 21 21
Hypervolemia 21 143
Urticaria 20 142
Bradycardia 20 20
Hypovolemia 19 19
Convulsion/Seizure 18 140
Cramp(s) /Muscle Spasm(s) 18 18
Cough 17 17
Hypernatremia 16 16
Fatigue 16 16
Cardiopulmonary Arrest 15 15
Anxiety 15 15
Test Result 15 15
Respiratory Failure 14 14
Confusion/ Disorientation 13 13
Exsanguination 13 135
Thrombocytopenia 12 256
Muscle Weakness 11 133
Myocardial Infarction 11 11
Peritonitis 10 10
Hypoxia 10 10
Fever 10 132
Fall 10 10
Cyanosis 9 9
Erythema 9 9
Diarrhea 9 9
Edema 9 9
Asthma 9 9
Injury 9 9
Respiratory Distress 9 9
Sepsis 9 131
Shock 9 131
Swelling 9 9
No Information 9 9
Shaking/Tremors 9 9
Pallor 9 9
Loss Of Pulse 8 8
Decreased Respiratory Rate 7 7
Respiratory Arrest 7 129
Hot Flashes/Flushes 7 7
Seizures 7 7
Pulmonary Edema 7 7
Cramp(s) 7 7
Apnea 7 129
Hypovolemic Shock 7 7
Stroke/CVA 6 6
Bruise/Contusion 6 6
Weakness 6 6
Blurred Vision 6 6
Pneumonia 6 6
Septic Shock 6 6
Wheezing 6 6
Thrombosis/Thrombus 6 6
Palpitations 6 6
Fungal Infection 6 6
Abdominal Distention 6 6
Bronchospasm 5 5
Lethargy 5 5
Local Reaction 5 5
Distress 5 5
Numbness 5 5

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 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 Fresenius Medical Care Renal Therapies Group, LLC III Jun-01-2019
24 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
25 NxStage MDS Corporation II Feb-27-2024
26 Outset Medical, Inc. II Jun-14-2024
27 Outset Medical, Inc. I Apr-12-2024
28 Outset Medical, Inc. II Mar-21-2022
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