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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, peritoneal, automatic delivery
Regulation Description Peritoneal dialysis system and accessories.
Product CodeFKX
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 6132 6132
2017 3129 3129
2018 5927 5927
2019 5972 5972
2020 4598 4598
2021 3682 3682

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 12198 12198
Adverse Event Without Identified Device or Use Problem 5853 5853
Device Displays Incorrect Message 3386 3386
Thermal Decomposition of Device 2679 2679
Improper or Incorrect Procedure or Method 1856 1856
Overfill 1185 1185
Disconnection 970 970
Loose or Intermittent Connection 648 648
Device Operates Differently Than Expected 629 629
Protective Measures Problem 507 507
Improper Flow or Infusion 327 327
Device Handling Problem 306 306
Device Contamination with Chemical or Other Material 295 295
Hole In Material 186 186
Detachment of Device or Device Component 179 179
Volume Accuracy Problem 155 155
Material Puncture/Hole 138 138
Break 128 128
Component Missing 121 121
Crack 107 107
Material Split, Cut or Torn 104 104
Overheating of Device 96 96
Connection Problem 77 77
Cut In Material 64 64
Sparking 62 62
Failure to Disconnect 59 59
Leak/Splash 59 59
Smoking 50 50
Air Leak 44 44
Fitting Problem 39 39
Air/Gas in Device 38 38
Grounding Malfunction 37 37
Use of Device Problem 28 28
Device Emits Odor 27 27
Melted 24 24
Device Issue 24 24
Incomplete or Inadequate Connection 22 22
Insufficient Information 19 19
Material Deformation 18 18
Scratched Material 16 16
Electrical /Electronic Property Problem 15 15
Misassembled 13 13
Material Perforation 13 13
Unintended Electrical Shock 11 11
Material Separation 10 10
Device Alarm System 9 9
Material Rupture 9 9
Material Integrity Problem 9 9
Bent 8 8
Filling Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Fire 6 6
Nonstandard Device 5 5
Image Display Error/Artifact 5 5
Kinked 5 5
Detachment Of Device Component 5 5
Contamination 5 5
Excessive Heating 5 5
Component Misassembled 4 4
Insufficient Heating 4 4
Mechanical Problem 4 4
Appropriate Term/Code Not Available 4 4
Temperature Problem 4 4
Device Operational Issue 3 3
Intermittent Shock/Stimulation 3 3
Misconnection 3 3
Product Quality Problem 3 3
Electrical Shorting 3 3
Arcing 2 2
Power Problem 2 2
Reflux within Device 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Delivered as Unsterile Product 2 2
Device Contamination with Body Fluid 2 2
Device Inoperable 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Failure to Power Up 2 2
Failure to Prime 2 2
Device Dislodged or Dislocated 2 2
Torn Material 2 2
Noise, Audible 2 2
Unexpected Shutdown 1 1
Incomplete or Inadequate Priming 1 1
Separation Problem 1 1
Environmental Compatibility Problem 1 1
Gas Leak 1 1
Human-Device Interface Problem 1 1
Calibration Problem 1 1
Defective Device 1 1
Difficult to Open or Close 1 1
Therapeutic or Diagnostic Output Failure 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Unsealed Device Packaging 1 1
Device Slipped 1 1
Obstruction of Flow 1 1
Excess Flow or Over-Infusion 1 1
Migration or Expulsion of Device 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11957 11958
No Consequences Or Impact To Patient 7767 7767
Peritonitis 3388 3388
No Clinical Signs, Symptoms or Conditions 2144 2144
Abdominal Pain 1028 1028
No Patient Involvement 919 919
Death 549 549
Hernia 464 464
Hypervolemia 434 434
Dyspnea 403 403
Unspecified Infection 343 343
Nausea 263 263
Abdominal Distention 255 255
Vomiting 230 230
No Information 198 198
Pain 174 174
Cardiac Arrest 162 162
Discomfort 149 149
Low Blood Pressure/ Hypotension 124 124
No Code Available 122 122
Electrolyte Imbalance 116 116
Chest Pain 112 112
Diarrhea 110 110
Constipation 103 103
Sepsis 102 102
High Blood Pressure/ Hypertension 98 98
Fever 92 92
Insufficient Information 90 90
Pneumonia 81 81
Increased Intra-Peritoneal Volume (IIPV) 80 80
Confusion/ Disorientation 75 75
Myocardial Infarction 71 71
Pleural Effusion 65 65
Pulmonary Edema 64 64
Weakness 64 64
Edema 61 61
Swelling 60 60
Congestive Heart Failure 48 48
Uremia 42 42
Blood Loss 42 42
Respiratory Failure 39 39
Anemia 37 37
Stroke/CVA 37 37
Malaise 32 32
Dizziness 29 29
Hyperglycemia 28 28
Loss of consciousness 28 28
Chills 27 27
Dehydration 27 27
Hypoglycemia 27 27
Hypoxia 26 26
Fall 26 26
Fatigue 26 26
Cardiopulmonary Arrest 25 25
Respiratory Distress 25 25
Bacterial Infection 24 24
Syncope 24 24
Weight Changes 23 23
Injury 22 22
Cramp(s) 22 22
Hypovolemia 20 20
Seizures 20 20
Urinary Tract Infection 19 19
Encephalopathy 19 19
Atrial Fibrillation 16 16
Arrhythmia 13 13
Electric Shock 13 13
Abdominal Cramps 13 13
Pericardial Effusion 13 13
Swelling/ Edema 12 12
Chest Tightness/Pressure 11 11
Hemorrhage/Bleeding 11 11
Tachycardia 10 10
Sudden Cardiac Death 10 10
Fungus 9 9
Inflammation 9 9
Septic Shock 9 9
Headache 7 7
Obstruction/Occlusion 7 7
Heart Failure 7 7
Shaking/Tremors 6 6
Cellulitis 6 6
Peritoneal Laceration(s) 6 6
Itching Sensation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Bone Fracture(s) 5 5
Bradycardia 5 5
Transient Ischemic Attack 5 5
Fainting 5 5
Abscess 5 5
Bowel Perforation 5 5
Cognitive Changes 4 4
Lethargy 4 4
Coma 4 4
Diaphoresis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pulmonary Embolism 4 4
Hematoma 4 4
Renal Failure 4 4
Fungal Infection 4 4

Recalls
Manufacturer Recall Class Date Posted
1 BAXTER HEALTHCARE CORPORATION II Aug-02-2021
2 Baxter Healthcare Corp II Sep-14-2017
3 Baxter Healthcare Corp. II Aug-22-2016
4 Baxter Healthcare Corp. II Apr-25-2016
5 Baxter Healthcare Corporation II Oct-03-2019
6 Baxter Healthcare Corporation II Feb-20-2019
7 Baxter Healthcare Corporation II Aug-02-2018
8 Baxter Healthcare Corporation II Aug-16-2017
9 Baxter Healthcare Corporation II Jan-19-2017
10 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
11 Fresenius Medical Care Holdings, Inc. II Nov-07-2020
12 Fresenius Medical Care Renal Therapies Group, LLC II Aug-05-2019
13 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
14 Fresenius Medical Care Renal Therapies Group, LLC II Jan-27-2016
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