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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 4
LIBERDI, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 5927 5927
2019 5972 5972
2020 4598 4598
2021 5076 5076
2022 4504 4504
2023 1244 1244

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 13455 13455
Adverse Event Without Identified Device or Use Problem 6137 6137
Thermal Decomposition of Device 3508 3508
Overfill 1044 1044
Disconnection 845 845
Protective Measures Problem 747 747
Loose or Intermittent Connection 586 586
Device Displays Incorrect Message 465 465
Improper Flow or Infusion 328 328
Detachment of Device or Device Component 242 242
Device Contamination with Chemical or Other Material 237 237
Material Puncture/Hole 198 198
Device Operates Differently Than Expected 194 194
Air/Gas in Device 167 167
Material Split, Cut or Torn 164 164
Component Missing 155 155
Break 114 114
Failure to Disconnect 114 114
Improper or Incorrect Procedure or Method 106 106
Crack 97 97
Sparking 80 80
Fitting Problem 65 65
Smoking 47 47
Incomplete or Inadequate Connection 36 36
Scratched Material 29 29
Unintended Electrical Shock 27 27
Connection Problem 26 26
Hole In Material 26 26
Melted 24 24
Overheating of Device 22 22
Cut In Material 19 19
Material Deformation 17 17
Volume Accuracy Problem 14 14
Material Separation 13 13
Grounding Malfunction 12 12
Material Perforation 12 12
Device Handling Problem 10 10
Excessive Heating 9 9
Material Rupture 9 9
Leak/Splash 7 7
Component Misassembled 6 6
Material Twisted/Bent 6 6
Fire 6 6
Material Integrity Problem 6 6
Image Display Error/Artifact 5 5
Device Issue 5 5
Filling Problem 5 5
Tear, Rip or Hole in Device Packaging 4 4
Electrical /Electronic Property Problem 4 4
Use of Device Problem 3 3
Intermittent Shock/Stimulation 3 3
Product Quality Problem 3 3
Mechanical Problem 3 3
Defective Device 2 2
Noise, Audible 2 2
Device Alarm System 2 2
Device Emits Odor 2 2
Arcing 2 2
Electrical Shorting 2 2
Unintended Movement 2 2
Unexpected Color 2 2
Misconnection 2 2
Device Contamination with Body Fluid 2 2
Bent 2 2
Device Dislodged or Dislocated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Delivered as Unsterile Product 2 2
Contamination /Decontamination Problem 1 1
Appropriate Term/Code Not Available 1 1
No Flow 1 1
Shipping Damage or Problem 1 1
Obstruction of Flow 1 1
Difficult to Open or Close 1 1
Gas/Air Leak 1 1
Fracture 1 1
Failure to Prime 1 1
Failure to Sense 1 1
Operating System Becomes Nonfunctional 1 1
Device Inoperable 1 1
Electro-Static Discharge 1 1
Defective Component 1 1
False Alarm 1 1
Contamination 1 1
Corroded 1 1
Display Difficult to Read 1 1
Detachment Of Device Component 1 1
Unsealed Device Packaging 1 1
Material Protrusion/Extrusion 1 1
Unexpected Shutdown 1 1
Restricted Flow rate 1 1
Free or Unrestricted Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Audible Prompt/Feedback Problem 1 1
Incomplete or Inadequate Priming 1 1
Separation Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Calibration Problem 1 1
Display or Visual Feedback Problem 1 1
Charred 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9900 9901
No Clinical Signs, Symptoms or Conditions 7177 7177
Peritonitis 3627 3627
No Consequences Or Impact To Patient 2850 2850
Abdominal Pain 1543 1543
No Patient Involvement 705 705
Unspecified Infection 500 500
Dyspnea 370 370
Hernia 339 339
Death 316 316
Hypervolemia 314 314
Insufficient Information 294 294
Nausea 290 290
Abdominal Distention 269 269
Vomiting 230 230
Increased Intra-Peritoneal Volume (IIPV) 216 216
No Information 186 186
Pain 156 156
Cardiac Arrest 147 147
Discomfort 117 117
Constipation 104 104
Diarrhea 100 100
Fever 97 97
Low Blood Pressure/ Hypotension 95 95
Chest Pain 84 84
Sepsis 83 83
High Blood Pressure/ Hypertension 74 74
Confusion/ Disorientation 66 66
Pulmonary Edema 65 65
Electrolyte Imbalance 58 58
No Code Available 55 55
Malaise 54 54
Pneumonia 51 51
Myocardial Infarction 50 50
Weakness 49 49
Edema 41 41
Swelling/ Edema 40 40
Swelling 39 39
Pleural Effusion 36 36
Uremia 32 32
Blood Loss 30 30
Fungal Infection 28 28
Loss of consciousness 28 28
Chills 28 28
Respiratory Failure 27 27
Weight Changes 27 27
Congestive Heart Failure 27 27
Dizziness 26 26
Stroke/CVA 26 26
Fatigue 26 26
Hypoxia 25 25
Dehydration 23 23
Bacterial Infection 21 21
Cramp(s) 21 21
Fall 20 20
Hypoglycemia 20 20
Cardiopulmonary Arrest 20 20
Hypovolemia 19 19
Hyperglycemia 19 19
Anemia 17 17
Heart Failure/Congestive Heart Failure 16 16
Seizures 13 13
Urinary Tract Infection 13 13
Atrial Fibrillation 13 13
Syncope 12 12
Septic Shock 12 12
Respiratory Distress 11 11
Lethargy 10 10
Inflammation 10 10
Encephalopathy 10 10
Fungus 9 9
Hypersensitivity/Allergic reaction 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Convulsion/Seizure 9 9
Arrhythmia 9 9
Tachycardia 9 9
Vertigo 8 8
Hemorrhage/Bleeding 8 8
Hematoma 7 7
Bowel Perforation 7 7
Bradycardia 6 6
Cellulitis 6 6
Pericardial Effusion 6 6
Abdominal Cramps 6 6
Headache 6 6
Shaking/Tremors 6 6
Injury 5 5
Viral Infection 5 5
Adhesion(s) 5 5
Angina 5 5
Burning Sensation 5 5
Bone Fracture(s) 4 4
Heart Failure 4 4
Diaphoresis 4 4
Obstruction/Occlusion 4 4
Electric Shock 4 4
Peritoneal Laceration(s) 4 4
Renal Failure 3 3
Transient Ischemic Attack 3 3
Arteriosclerosis/ Atherosclerosis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 BAXTER HEALTHCARE CORPORATION II Aug-02-2021
2 Baxter Healthcare Corporation II Apr-01-2023
3 Baxter Healthcare Corporation II May-27-2022
4 Baxter Healthcare Corporation II Oct-03-2019
5 Baxter Healthcare Corporation II Feb-20-2019
6 Baxter Healthcare Corporation II Aug-02-2018
7 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
8 Fresenius Medical Care Holdings, Inc. II Nov-07-2020
9 Fresenius Medical Care Renal Therapies Group, LLC II Aug-05-2019
10 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
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