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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, administration, for peritoneal dialysis, disposable
Product CodeKDJ
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 3
FRESENSIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
PURACATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7677 7677
2015 6870 6870
2016 7045 7045
2017 4636 4636
2018 3379 3379
2019 2456 2456
2020 2870 2870
2021 3167 3167
2022 2927 2927
2023 2947 2947
2024 1171 1171

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25367 25367
Improper or Incorrect Procedure or Method 5879 5879
Fluid/Blood Leak 3396 3396
Disconnection 2364 2364
Detachment of Device or Device Component 1754 1754
Crack 1433 1433
Insufficient Information 1357 1357
Break 699 699
Contamination 665 665
Product Quality Problem 636 636
Loose or Intermittent Connection 633 633
Connection Problem 511 511
Failure to Disconnect 297 297
Leak/Splash 291 291
Device Contamination with Chemical or Other Material 282 282
Fitting Problem 280 280
Unsealed Device Packaging 255 255
Difficult to Open or Close 215 215
Component Missing 148 148
Incomplete or Inadequate Connection 139 139
Packaging Problem 120 120
Material Puncture/Hole 110 110
Detachment Of Device Component 108 108
Device Operates Differently Than Expected 107 107
Tear, Rip or Hole in Device Packaging 102 102
Hole In Material 97 97
Material Separation 94 94
Free or Unrestricted Flow 92 92
Device Displays Incorrect Message 88 88
Misassembled 86 86
Delivered as Unsterile Product 51 51
Protective Measures Problem 51 51
Material Split, Cut or Torn 49 49
Misconnection 46 46
Mechanical Problem 44 44
Nonstandard Device 40 40
No Flow 39 39
Use of Device Problem 32 32
Cut In Material 30 30
Material Deformation 28 28
Improper Flow or Infusion 27 27
Positioning Problem 25 25
Device Packaging Compromised 23 23
Component Falling 23 23
Device Damaged Prior to Use 19 19
Material Integrity Problem 18 18
Material Discolored 17 17
Fracture 15 15
Defective Component 12 12
Device Slipped 12 12
Material Rupture 9 9
Air Leak 8 8
Appropriate Term/Code Not Available 8 8
Component Misassembled 7 7
Device Dislodged or Dislocated 7 7
Noise, Audible 6 6
Scratched Material 6 6
Material Perforation 6 6
Separation Failure 5 5
Degraded 5 5
Radiation Underexposure 5 5
Air/Gas in Device 5 5
Contamination /Decontamination Problem 5 5
Material Twisted/Bent 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Handling Problem 4 4
Material Disintegration 4 4
Complete Blockage 4 4
Kinked 4 4
Device Difficult to Setup or Prepare 4 4
Shipping Damage or Problem 4 4
Inadequate or Insufficient Training 3 3
Defective Device 3 3
Structural Problem 3 3
Melted 3 3
Partial Blockage 3 3
Device Reprocessing Problem 3 3
Torn Material 3 3
Unintended Movement 3 3
Separation Problem 3 3
Migration 3 3
Device Markings/Labelling Problem 3 3
Infusion or Flow Problem 3 3
Mechanical Jam 3 3
Microbial Contamination of Device 3 3
Contamination of Device Ingredient or Reagent 2 2
Device Unsafe to Use in Environment 2 2
Labelling, Instructions for Use or Training Problem 2 2
Expiration Date Error 2 2
Inappropriate Waveform 2 2
Malposition of Device 2 2
Incomplete or Missing Packaging 2 2
Overfill 2 2
Sticking 2 2
Suction Problem 1 1
Insufficient Flow or Under Infusion 1 1
Shelf Life Exceeded 1 1
Therapy Delivered to Incorrect Body Area 1 1
Obstruction of Flow 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 30706 30706
No Consequences Or Impact To Patient 5137 5137
Abdominal Pain 5087 5087
No Clinical Signs, Symptoms or Conditions 4119 4119
No Known Impact Or Consequence To Patient 1646 1646
Death 1334 1334
Unspecified Infection 1304 1304
No Patient Involvement 1284 1284
Fever 889 889
Vomiting 646 646
Diarrhea 532 532
Sepsis 320 320
Nausea 276 276
Pain 261 261
Bacterial Infection 172 172
Malaise 127 127
Weakness 103 103
Chills 100 100
Cardiac Arrest 81 81
Low Blood Pressure/ Hypotension 75 75
Septic Shock 61 61
Constipation 54 54
Fatigue 52 52
Abdominal Cramps 46 46
Fungal Infection 44 44
Discomfort 43 43
Inflammation 40 40
Test Result 39 39
Abdominal Distention 32 32
Decreased Appetite 28 28
Purulent Discharge 27 27
Cramp(s) 26 26
Dyspnea 25 25
Myocardial Infarction 24 24
Dizziness 23 23
Heart Failure 22 22
Insufficient Information 22 22
Staphylococcus Aureus 21 21
Dehydration 20 20
Lethargy 19 19
Muscle Weakness 18 18
Confusion/ Disorientation 17 17
Complaint, Ill-Defined 17 17
Weight Changes 16 16
Multiple Organ Failure 16 16
No Code Available 15 15
Swelling 15 15
High Blood Pressure/ Hypertension 14 14
Injury 12 12
Shaking/Tremors 11 11
Respiratory Failure 10 10
Fall 10 10
Renal Disease, End Stage 10 10
Abscess 10 10
Cramp(s) /Muscle Spasm(s) 10 10
No Information 9 10
Renal Failure 9 9
Loss of consciousness 9 9
Ascites 8 8
Hyperthermia 7 7
Edema 7 7
Swelling/ Edema 7 7
Fistula 6 6
Cardiopulmonary Arrest 6 6
Stroke/CVA 6 6
Chest Pain 6 6
Hypoglycemia 6 6
Pneumonia 6 6
Respiratory Distress 5 5
Fainting 5 5
Headache 5 5
Pallor 5 5
Tachycardia 5 5
Urinary Tract Infection 5 5
Shock 4 4
Cardiogenic Shock 4 4
Electrolyte Imbalance 4 4
Obstruction/Occlusion 4 4
Rash 4 4
Fluid Discharge 4 4
Bowel Perforation 3 3
Alteration In Body Temperature 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Alteration in Body Temperature 3 3
Pleural Effusion 3 3
Hypersensitivity/Allergic reaction 3 3
Hemorrhage/Bleeding 3 3
Itching Sensation 3 3
Dysphagia/ Odynophagia 3 3
Diaphoresis 3 3
Distress 3 3
Sleep Dysfunction 3 3
Ambulation Difficulties 3 3
Hernia 3 3
Burning Sensation 3 3
Thyroid Problems 2 2
Discharge 2 2
Cognitive Changes 2 2
Irritability 2 2
Reaction 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp II Oct-17-2014
2 Baxter Healthcare Corp. II Oct-30-2015
3 Baxter Healthcare Corp. II Aug-27-2015
4 Baxter Healthcare Corp. II Aug-31-2009
5 Baxter Healthcare Corporation II Mar-03-2023
6 Baxter Healthcare Corporation II May-27-2022
7 Baxter Healthcare Corporation II Mar-29-2022
8 Baxter Healthcare Corporation II Feb-08-2022
9 Baxter Healthcare Corporation II Jan-04-2021
10 Baxter Healthcare Corporation II Jun-02-2017
11 Fresenius Medical Care Holdings, Inc. I Mar-26-2024
12 Fresenius Medical Care Holdings, Inc. II Dec-07-2023
13 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
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