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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

MDR Year MDR Reports MDR Events
2017 3129 3129
2018 5927 5927
2019 5972 5972
2020 4598 4598
2021 5076 5076
2022 2974 2974

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 13462 13462
Adverse Event Without Identified Device or Use Problem 6232 6232
Thermal Decomposition of Device 3225 3225
Overfill 1129 1129
Disconnection 945 945
Device Displays Incorrect Message 814 814
Protective Measures Problem 652 652
Loose or Intermittent Connection 613 613
Improper Flow or Infusion 328 328
Device Operates Differently Than Expected 294 294
Device Contamination with Chemical or Other Material 253 253
Detachment of Device or Device Component 229 229
Improper or Incorrect Procedure or Method 220 220
Material Puncture/Hole 174 174
Component Missing 145 145
Material Split, Cut or Torn 141 141
Break 124 124
Air/Gas in Device 120 120
Hole In Material 117 117
Crack 105 105
Failure to Disconnect 102 102
Device Handling Problem 94 94
Sparking 80 80
Overheating of Device 68 68
Fitting Problem 58 58
Smoking 49 49
Cut In Material 46 46
Connection Problem 43 43
Volume Accuracy Problem 43 43
Leak/Splash 39 39
Incomplete or Inadequate Connection 29 29
Grounding Malfunction 28 28
Melted 26 26
Scratched Material 22 22
Material Deformation 18 18
Unintended Electrical Shock 18 18
Device Issue 18 18
Use of Device Problem 16 16
Material Separation 13 13
Material Perforation 12 12
Misassembled 12 12
Material Rupture 11 11
Electrical /Electronic Property Problem 9 9
Excessive Heating 9 9
Material Integrity Problem 7 7
Filling Problem 7 7
Air Leak 7 7
Bent 7 7
Tear, Rip or Hole in Device Packaging 6 6
Fire 5 5
Image Display Error/Artifact 5 5
Component Misassembled 5 5
Misconnection 4 4
Detachment Of Device Component 4 4
Contamination 4 4
Device Alarm System 3 3
Mechanical Problem 3 3
Product Quality Problem 3 3
Intermittent Shock/Stimulation 3 3
Appropriate Term/Code Not Available 3 3
Material Twisted/Bent 3 3
Electrical Shorting 3 3
Temperature Problem 3 3
Power Problem 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Noise, Audible 2 2
Unexpected Color 2 2
Device Inoperable 2 2
Device Contamination with Body Fluid 2 2
Arcing 2 2
Device Dislodged or Dislocated 2 2
Device Operational Issue 2 2
Delivered as Unsterile Product 2 2
Device Emits Odor 2 2
Kinked 2 2
Corroded 2 2
Charred 1 1
No Audible Alarm 1 1
Partial Blockage 1 1
Restricted Flow rate 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Moisture Damage 1 1
Unsealed Device Packaging 1 1
Failure to Power Up 1 1
Failure to Prime 1 1
Difficult to Open or Close 1 1
Calibration Problem 1 1
Defective Device 1 1
Obstruction of Flow 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Incomplete or Inadequate Priming 1 1
Separation Problem 1 1
Unexpected Shutdown 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11131 11132
No Clinical Signs, Symptoms or Conditions 5259 5259
No Consequences Or Impact To Patient 3674 3674
Peritonitis 3647 3647
Abdominal Pain 1373 1373
No Patient Involvement 776 776
Death 443 443
Dyspnea 426 426
Unspecified Infection 401 401
Hypervolemia 396 396
Hernia 372 372
Nausea 298 298
Abdominal Distention 274 274
Vomiting 246 246
Insufficient Information 196 196
No Information 194 194
Pain 169 169
Cardiac Arrest 162 162
Increased Intra-Peritoneal Volume (IIPV) 162 162
Discomfort 141 141
Low Blood Pressure/ Hypotension 116 116
Diarrhea 114 114
Constipation 110 110
Fever 108 108
Sepsis 108 108
Chest Pain 106 106
Electrolyte Imbalance 97 97
High Blood Pressure/ Hypertension 94 94
No Code Available 85 85
Confusion/ Disorientation 73 73
Pneumonia 70 70
Pulmonary Edema 70 70
Myocardial Infarction 64 64
Weakness 59 59
Edema 59 59
Pleural Effusion 54 54
Swelling 53 53
Malaise 49 49
Uremia 43 43
Blood Loss 41 41
Congestive Heart Failure 39 39
Respiratory Failure 38 38
Anemia 32 32
Stroke/CVA 32 32
Dizziness 32 32
Fatigue 28 28
Hypoxia 28 28
Loss of consciousness 28 28
Weight Changes 27 27
Swelling/ Edema 27 27
Chills 27 27
Hyperglycemia 26 26
Dehydration 26 26
Bacterial Infection 24 24
Cardiopulmonary Arrest 23 23
Hypoglycemia 23 23
Fall 23 23
Cramp(s) 22 22
Respiratory Distress 22 22
Syncope 20 20
Urinary Tract Infection 19 19
Seizures 18 18
Hypovolemia 18 18
Encephalopathy 18 18
Atrial Fibrillation 17 17
Injury 14 14
Hemorrhage/Bleeding 12 12
Inflammation 11 11
Pericardial Effusion 11 11
Fungal Infection 11 11
Chest Tightness/Pressure 11 11
Abdominal Cramps 11 11
Heart Failure/Congestive Heart Failure 10 10
Septic Shock 10 10
Arrhythmia 10 10
Fungus 9 9
Tachycardia 9 9
Lethargy 9 9
Shaking/Tremors 7 7
Obstruction/Occlusion 7 7
Heart Failure 7 7
Headache 7 7
Cellulitis 6 6
Vertigo 6 6
Bone Fracture(s) 6 6
Convulsion/Seizure 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Bowel Perforation 5 5
Transient Ischemic Attack 5 5
Burning Sensation 5 5
Bradycardia 5 5
Abscess 5 5
Itching Sensation 5 5
Hematoma 4 4
Pulmonary Embolism 4 4
Angina 4 4
Bronchitis 4 4
Viral Infection 4 4
Electric Shock 4 4
Ascites 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 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 Baxter Healthcare Corporation II Aug-16-2017
8 Baxter Healthcare Corporation II Jan-19-2017
9 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
10 Fresenius Medical Care Holdings, Inc. II Nov-07-2020
11 Fresenius Medical Care Renal Therapies Group, LLC II Aug-05-2019
12 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
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