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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
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 6
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 899 899

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6841 7086
Adverse Event Without Identified Device or Use Problem 1125 2711
Thermal Decomposition of Device 659 659
Break 441 441
Inadequate Ultra Filtration 321 321
Crack 289 289
Leak/Splash 282 282
Device Contamination with Chemical or Other Material 280 280
Melted 200 200
Disconnection 125 125
Smoking 97 97
Improper or Incorrect Procedure or Method 96 218
Air/Gas in Device 93 215
Obstruction of Flow 80 80
Protective Measures Problem 78 78
Device Displays Incorrect Message 62 62
Device Alarm System 56 56
Detachment of Device or Device Component 52 52
No Apparent Adverse Event 51 51
Improper Flow or Infusion 44 44
Loose or Intermittent Connection 43 43
Material Puncture/Hole 40 40
Therapeutic or Diagnostic Output Failure 37 159
Mechanical Problem 35 35
Sparking 34 34
Patient-Device Incompatibility 32 154
Filtration Problem 30 30
Fire 27 27
Reflux within Device 26 26
Unexpected Shutdown 26 26
No Audible Alarm 25 25
Material Split, Cut or Torn 24 24
Pressure Problem 23 23
Insufficient Information 22 144
Infusion or Flow Problem 21 21
Defective Device 20 20
Material Rupture 18 140
Use of Device Problem 17 17
Output Problem 16 16
Product Quality Problem 16 16
Complete Blockage 15 15
No Display/Image 15 15
Display or Visual Feedback Problem 15 15
Gas/Air Leak 15 15
Calibration Problem 14 14
Defective Component 14 14
Arcing 13 13
No Flow 13 13
Connection Problem 12 12
Device Dislodged or Dislocated 12 134
Filling Problem 12 12
Defective Alarm 11 11
Failure to Prime 10 10
Backflow 9 9
Patient Device Interaction Problem 9 9
Physical Resistance/Sticking 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
Contamination 5 5
Fracture 5 5
Overheating of Device 5 5
Packaging Problem 5 5
Material Deformation 5 5
Device Sensing Problem 5 5
Biocompatibility 5 5
Unexpected Therapeutic Results 5 5
Material Perforation 5 5
Complete Loss of Power 5 5
Device Fell 4 4
Audible Prompt/Feedback Problem 4 4
Incomplete or Inadequate Connection 4 4
Failure to Disconnect 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Failure of Device to Self-Test 4 4
Failure to Power Up 4 4
Device Appears to Trigger Rejection 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Pumping Stopped 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
Device Tipped Over 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Inadequate Filtration Process 3 3
Temperature Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5197 5198
Hemorrhage/Bleeding 1388 1998
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 331 697
Hypersensitivity/Allergic reaction 210 210
Dyspnea 210 455
Insufficient Information 200 444
Cardiac Arrest 184 550
Blood Loss 162 162
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
Death 128 372
Loss of consciousness 126 614
Nausea 89 456
Itching Sensation 84 206
Hemolysis 76 76
Dizziness 75 75
Vomiting 74 440
Chest Pain 74 74
High Blood Pressure/ Hypertension 63 185
Abdominal Pain 56 178
Diaphoresis 42 43
Low Oxygen Saturation 38 38
Headache 35 157
Malaise 35 157
Tachycardia 34 34
Reaction 33 33
Discomfort 32 32
Anemia 27 27
Rash 26 26
Sweating 24 146
Chest Tightness/Pressure 23 23
Weight Changes 23 23
No Code Available 23 23
Air Embolism 23 23
Chills 22 266
Swelling/ Edema 22 22
Syncope/Fainting 21 21
Hypervolemia 21 143
Urticaria 20 142
Pain 20 20
Hypovolemia 19 19
Bradycardia 19 19
Convulsion/Seizure 18 140
Cough 16 16
Hypernatremia 16 16
Fatigue 16 16
Cardiopulmonary Arrest 15 15
Anxiety 15 15
Test Result 15 15
Cramp(s) /Muscle Spasm(s) 15 15
Respiratory Failure 14 14
Exsanguination 13 135
Muscle Weakness 11 133
Myocardial Infarction 11 11
Confusion/ Disorientation 11 11
Thrombocytopenia 11 255
Hypoxia 10 10
Fall 10 10
Fever 10 132
Peritonitis 10 10
Injury 9 9
Respiratory Distress 9 9
Sepsis 9 131
Swelling 9 9
Shock 9 131
Erythema 9 9
Diarrhea 9 9
Edema 9 9
Asthma 9 9
Shaking/Tremors 9 9
No Information 9 9
Loss Of Pulse 8 8
Pallor 8 8
Cyanosis 8 8
Apnea 7 129
Hypovolemic Shock 7 7
Hot Flashes/Flushes 7 7
Seizures 7 7
Pulmonary Edema 7 7
Cramp(s) 7 7
Decreased Respiratory Rate 7 7
Respiratory Arrest 7 129
Thrombosis/Thrombus 6 6
Palpitations 6 6
Blurred Vision 6 6
Fungal Infection 6 6
Pneumonia 6 6
Septic Shock 6 6
Weakness 6 6
Bruise/Contusion 6 6
Syncope 5 5
Arrhythmia 5 5
Stroke/CVA 5 5
Local Reaction 5 5
Distress 5 5
Lethargy 5 5
Bronchospasm 5 5
Abdominal Distention 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 May-17-2024
17 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
18 Fresenius Medical Care Holdings, Inc. II Dec-20-2022
19 Fresenius Medical Care Holdings, Inc. II Jun-30-2022
20 Fresenius Medical Care Holdings, Inc. II Apr-20-2020
21 Fresenius Medical Care Holdings, Inc. II Mar-20-2020
22 Fresenius Medical Care Renal Therapies Group, LLC III Jun-01-2019
23 Nikkiso Ltd - Shizuoka Plant II Jan-05-2022
24 NxStage MDS Corporation II Feb-27-2024
25 Outset Medical, Inc. I Apr-12-2024
26 Outset Medical, Inc. II Mar-21-2022
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