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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
Product CodeFKX
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CLOUDCATH
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
IREN-MEDICAL, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5972 5972
2020 4598 4598
2021 5076 5076
2022 4503 4503
2023 3913 3913
2024 1013 1013

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 12159 12159
Adverse Event Without Identified Device or Use Problem 5751 5751
Thermal Decomposition of Device 3595 3595
Protective Measures Problem 919 919
Disconnection 777 777
Overfill 685 685
Loose or Intermittent Connection 495 495
Improper Flow or Infusion 274 274
Detachment of Device or Device Component 262 262
Air/Gas in Device 238 238
Material Puncture/Hole 233 233
Device Contamination with Chemical or Other Material 218 218
Material Split, Cut or Torn 182 182
Component Missing 163 163
Failure to Disconnect 141 141
Device Displays Incorrect Message 140 140
Improper or Incorrect Procedure or Method 113 113
Break 107 107
Crack 105 105
Sparking 85 85
Fitting Problem 68 68
Incomplete or Inadequate Connection 62 62
Smoking 44 44
Unintended Electrical Shock 33 33
Connection Problem 30 30
Scratched Material 29 29
Output Problem 27 27
Melted 24 24
Material Deformation 16 16
Material Separation 14 14
Material Rupture 10 10
Material Twisted/Bent 10 10
Excessive Heating 9 9
Component Misassembled 8 8
Fire 8 8
Leak/Splash 7 7
Obstruction of Flow 7 7
Malposition of Device 5 5
Material Integrity Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Insufficient Information 5 5
Noise, Audible 4 4
Positioning Problem 4 4
Defective Device 3 3
Intermittent Shock/Stimulation 3 3
Grounding Malfunction 3 3
Display or Visual Feedback Problem 3 3
Filling Problem 3 3
Contamination 3 3
Product Quality Problem 3 3
Mechanical Problem 2 2
Misconnection 2 2
Delivered as Unsterile Product 2 2
Use of Device Problem 2 2
Material Perforation 2 2
Gas/Air Leak 2 2
Unintended Movement 2 2
Device Handling Problem 2 2
Unexpected Color 2 2
Temperature Problem 1 1
Patient Device Interaction Problem 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Unexpected Shutdown 1 1
Audible Prompt/Feedback Problem 1 1
Incomplete or Inadequate Priming 1 1
Separation Problem 1 1
Unclear Information 1 1
Human-Device Interface Problem 1 1
Free or Unrestricted Flow 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Power Problem 1 1
Operating System Becomes Nonfunctional 1 1
Material Protrusion/Extrusion 1 1
No Flow 1 1
Defective Component 1 1
Solder Joint Fracture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Arcing 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Contamination /Decontamination Problem 1 1
Failure to Sense 1 1
Shipping Damage or Problem 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Failure to Prime 1 1
Corroded 1 1
Device Alarm System 1 1
False Alarm 1 1
Loss of or Failure to Bond 1 1
Display Difficult to Read 1 1
Restricted Flow rate 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9726 9726
No Known Impact Or Consequence To Patient 6488 6488
Peritonitis 3688 3688
No Consequences Or Impact To Patient 1972 1972
Abdominal Pain 1801 1801
No Patient Involvement 584 584
Unspecified Infection 520 520
Insufficient Information 365 365
Dyspnea 302 302
Increased Intra-Peritoneal Volume (IIPV) 298 298
Hernia 259 259
Nausea 228 228
Abdominal Distention 220 220
Death 207 207
Hypervolemia 190 190
Vomiting 182 182
Cardiac Arrest 137 137
No Information 133 133
Pain 120 120
Fever 111 111
Diarrhea 90 90
Constipation 74 74
Low Blood Pressure/ Hypotension 64 64
Malaise 62 62
Sepsis 58 58
Fungal Infection 56 56
Discomfort 52 52
Confusion/ Disorientation 51 51
Chest Pain 51 51
Swelling/ Edema 48 48
Pulmonary Edema 47 47
Electrolyte Imbalance 42 42
Myocardial Infarction 42 42
High Blood Pressure/ Hypertension 41 41
Fatigue 35 35
Pleural Effusion 30 30
Pneumonia 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
No Code Available 24 24
Chills 24 24
Loss of consciousness 23 23
Weakness 22 22
Dizziness 21 21
Fall 20 20
Edema 19 19
Swelling 19 19
Hypoglycemia 18 18
Heart Failure/Congestive Heart Failure 18 18
Uremia 17 17
Urinary Tract Infection 16 16
Respiratory Failure 16 16
Hypoxia 16 16
Dehydration 15 15
Stroke/CVA 15 15
Bacterial Infection 15 15
Weight Changes 13 13
Blood Loss 12 12
Lethargy 12 12
Hypersensitivity/Allergic reaction 11 11
Hemorrhage/Bleeding 11 11
Cardiopulmonary Arrest 10 10
Septic Shock 10 10
Cramp(s) 10 10
Hypovolemia 10 10
Convulsion/Seizure 10 10
Arrhythmia 9 9
Hyperglycemia 9 9
Inflammation 8 8
Peritoneal Laceration(s) 8 8
Tachycardia 8 8
Vertigo 8 8
Seizures 7 7
Fungus 7 7
Anemia 7 7
Syncope 6 6
Atrial Fibrillation 6 6
Congestive Heart Failure 6 6
Shaking/Tremors 6 6
Bowel Perforation 5 5
Cellulitis 5 5
Hematoma 5 5
Muscle Weakness 4 4
Encephalopathy 4 4
Angina 4 4
Bradycardia 4 4
Electric Shock 4 4
Abdominal Cramps 4 4
Burning Sensation 4 4
Viral Infection 4 4
Syncope/Fainting 4 4
Arteriosclerosis/ Atherosclerosis 3 3
Pericarditis 3 3
Cough 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Gastrointestinal Hemorrhage 3 3
Rupture 3 3
Transient Ischemic Attack 3 3
Renal Failure 3 3
Respiratory Distress 3 3
Diaphoresis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 BAXTER HEALTHCARE CORPORATION II Aug-02-2021
2 Baxter Healthcare Corporation II Dec-14-2023
3 Baxter Healthcare Corporation II Apr-01-2023
4 Baxter Healthcare Corporation II May-27-2022
5 Baxter Healthcare Corporation II Oct-03-2019
6 Baxter Healthcare Corporation II Feb-20-2019
7 Fresenius Medical Care Holdings, Inc. III Dec-26-2023
8 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
9 Fresenius Medical Care Holdings, Inc. II Nov-07-2020
10 Fresenius Medical Care Renal Therapies Group, LLC II Aug-05-2019
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