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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 1469 1469

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 12831 12831
Adverse Event Without Identified Device or Use Problem 5746 5746
Thermal Decomposition of Device 3054 3054
Overfill 1105 1105
Disconnection 877 877
Device Displays Incorrect Message 814 814
Protective Measures Problem 604 604
Loose or Intermittent Connection 588 588
Improper Flow or Infusion 328 328
Device Operates Differently Than Expected 294 294
Device Contamination with Chemical or Other Material 241 241
Detachment of Device or Device Component 221 221
Improper or Incorrect Procedure or Method 213 213
Material Puncture/Hole 162 162
Component Missing 136 136
Material Split, Cut or Torn 131 131
Hole In Material 117 117
Break 116 116
Device Handling Problem 94 94
Failure to Disconnect 87 87
Crack 86 86
Air/Gas in Device 86 86
Sparking 71 71
Overheating of Device 68 68
Fitting Problem 52 52
Smoking 46 46
Cut In Material 46 46
Connection Problem 43 43
Volume Accuracy Problem 43 43
Leak/Splash 39 39
Grounding Malfunction 28 28
Incomplete or Inadequate Connection 27 27
Melted 24 24
Device Issue 18 18
Material Deformation 18 18
Scratched Material 16 16
Unintended Electrical Shock 16 16
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 8 8
Material Integrity Problem 7 7
Filling Problem 7 7
Air Leak 7 7
Bent 7 7
Fire 5 5
Image Display Error/Artifact 5 5
Tear, Rip or Hole in Device Packaging 5 5
Detachment Of Device Component 4 4
Contamination 4 4
Component Misassembled 4 4
Appropriate Term/Code Not Available 3 3
Electrical Shorting 3 3
Temperature Problem 3 3
Device Alarm System 3 3
Misconnection 3 3
Mechanical Problem 3 3
Product Quality Problem 3 3
Intermittent Shock/Stimulation 3 3
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
Power Problem 2 2
Material Twisted/Bent 2 2
Insufficient Information 2 2
Noise, Audible 2 2
Unexpected Color 2 2
Incomplete or Inadequate Priming 1 1
Separation Problem 1 1
Unexpected Shutdown 1 1
No Flow 1 1
Environmental Compatibility Problem 1 1
Free or Unrestricted Flow 1 1
Gas Leak 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Unintended Movement 1 1
Moisture Damage 1 1
Unsealed Device Packaging 1 1
Failure to Power Up 1 1
Failure to Prime 1 1
No Audible Alarm 1 1
Partial Blockage 1 1
Corroded 1 1
Charred 1 1
Restricted Flow rate 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Difficult to Open or Close 1 1
Calibration 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 4276 4276
No Consequences Or Impact To Patient 3674 3674
Peritonitis 3321 3321
Abdominal Pain 1189 1189
No Patient Involvement 776 776
Death 443 443
Dyspnea 407 407
Hypervolemia 384 384
Unspecified Infection 360 360
Hernia 354 354
Nausea 276 276
Abdominal Distention 262 262
Vomiting 233 233
No Information 194 194
Pain 159 159
Cardiac Arrest 151 151
Insufficient Information 146 146
Discomfort 140 140
Increased Intra-Peritoneal Volume (IIPV) 138 138
Low Blood Pressure/ Hypotension 113 113
Diarrhea 104 104
Sepsis 103 103
Chest Pain 101 101
Constipation 101 101
Fever 99 99
High Blood Pressure/ Hypertension 92 92
Electrolyte Imbalance 92 92
No Code Available 85 85
Confusion/ Disorientation 72 72
Pulmonary Edema 68 68
Pneumonia 66 66
Myocardial Infarction 60 60
Weakness 59 59
Edema 59 59
Swelling 53 53
Pleural Effusion 51 51
Uremia 43 43
Malaise 43 43
Blood Loss 41 41
Congestive Heart Failure 39 39
Respiratory Failure 37 37
Anemia 32 32
Stroke/CVA 32 32
Dizziness 29 29
Fatigue 28 28
Hypoxia 27 27
Weight Changes 27 27
Loss of consciousness 26 26
Chills 26 26
Hyperglycemia 25 25
Bacterial Infection 24 24
Dehydration 24 24
Swelling/ Edema 24 24
Cardiopulmonary Arrest 23 23
Hypoglycemia 22 22
Fall 22 22
Cramp(s) 22 22
Respiratory Distress 22 22
Syncope 20 20
Urinary Tract Infection 19 19
Seizures 18 18
Encephalopathy 18 18
Atrial Fibrillation 17 17
Hypovolemia 17 17
Injury 14 14
Hemorrhage/Bleeding 12 12
Inflammation 11 11
Pericardial Effusion 11 11
Chest Tightness/Pressure 11 11
Abdominal Cramps 11 11
Arrhythmia 10 10
Fungus 9 9
Septic Shock 9 9
Tachycardia 8 8
Lethargy 8 8
Obstruction/Occlusion 7 7
Fungal Infection 7 7
Heart Failure/Congestive Heart Failure 7 7
Heart Failure 7 7
Headache 7 7
Cellulitis 6 6
Shaking/Tremors 6 6
Bowel Perforation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Bradycardia 5 5
Abscess 5 5
Itching Sensation 5 5
Bone Fracture(s) 5 5
Transient Ischemic Attack 4 4
Burning Sensation 4 4
Hematoma 4 4
Pulmonary Embolism 4 4
Angina 4 4
Bronchitis 4 4
Convulsion/Seizure 4 4
Electric Shock 4 4
Diaphoresis 4 4
Sudden Cardiac Death 4 4
Reaction 3 3

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 Oct-03-2019
4 Baxter Healthcare Corporation II Feb-20-2019
5 Baxter Healthcare Corporation II Aug-02-2018
6 Baxter Healthcare Corporation II Aug-16-2017
7 Baxter Healthcare Corporation II Jan-19-2017
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
11 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
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