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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 CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CLOUDCATH
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 6
IREN-MEDICAL, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 28289 28289
2015 24663 24663
2016 6137 6137
2017 3127 3127
2018 5927 5927
2019 5972 5972
2020 4598 4598
2021 5076 5076
2022 4503 4503
2023 3913 3913
2024 1355 1355

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 26966 26966
Fluid/Blood Leak 19015 19015
Adverse Event Without Identified Device or Use Problem 12937 12937
Device Operates Differently Than Expected 11107 11107
Improper or Incorrect Procedure or Method 9204 9204
Overfill 7050 7050
Thermal Decomposition of Device 4098 4098
Disconnection 1838 1838
Air Leak 1806 1806
Loose or Intermittent Connection 1110 1110
Insufficient Information 974 974
Protective Measures Problem 945 945
Volume Accuracy Problem 579 579
Device Handling Problem 542 542
Device Contamination with Chemical or Other Material 472 472
Improper Flow or Infusion 332 332
Leak/Splash 311 311
Hole In Material 295 295
Detachment of Device or Device Component 272 272
Material Puncture/Hole 270 270
Component Missing 268 268
Break 263 263
Connection Problem 257 257
Air/Gas in Device 245 245
Crack 237 237
Material Split, Cut or Torn 207 207
Cut In Material 165 165
Failure to Disconnect 154 154
Overheating of Device 133 133
Device Emits Odor 126 126
Fitting Problem 120 120
Grounding Malfunction 119 119
Sparking 112 112
Degraded 111 111
Failure to Prime 97 97
Device Alarm System 95 95
Smoking 92 92
Contamination 77 77
Excess Flow or Over-Infusion 70 70
Mechanical Problem 67 67
Incomplete or Inadequate Connection 65 65
Use of Device Problem 56 56
Electrical /Electronic Property Problem 42 42
Melted 39 39
Detachment Of Device Component 37 37
Unintended Electrical Shock 37 37
Scratched Material 35 35
Component Falling 31 31
Output Problem 28 28
Material Deformation 28 28
Device Inoperable 27 27
Device Issue 25 25
Noise, Audible 25 25
Kinked 22 22
Material Separation 21 21
Product Quality Problem 20 20
Material Rupture 19 19
Inappropriate/Inadequate Shock/Stimulation 19 19
Filling Problem 19 19
Material Integrity Problem 19 19
Failure of Device to Self-Test 15 15
Material Perforation 14 14
Communication or Transmission Problem 14 14
Tear, Rip or Hole in Device Packaging 13 13
Fire 13 13
Misassembled 13 13
Temperature Problem 13 13
Material Twisted/Bent 12 12
Appropriate Term/Code Not Available 12 12
Bent 12 12
Insufficient Heating 10 10
Defective Device 10 10
Device Slipped 10 10
Invalid Sensing 9 9
Misconnection 9 9
Occlusion Within Device 9 9
Excessive Heating 9 9
Moisture or Humidity Problem 9 9
Component Misassembled 8 8
Failure to Power Up 8 8
Obstruction of Flow 8 8
High Readings 7 7
Reflux within Device 7 7
Malposition of Device 6 6
Loss of Power 6 6
Image Display Error/Artifact 6 6
Torn Material 6 6
No Flow 6 6
Difficult to Open or Close 6 6
Human-Device Interface Problem 6 6
Therapeutic or Diagnostic Output Failure 5 5
Positioning Problem 5 5
No Display/Image 5 5
Display or Visual Feedback Problem 5 5
Nonstandard Device 5 5
Partial Blockage 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Device Damaged Prior to Use 4 4
Intermittent Shock/Stimulation 4 4
Device Operational Issue 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 45044 45045
No Consequences Or Impact To Patient 20473 20473
No Clinical Signs, Symptoms or Conditions 9974 9974
Peritonitis 7758 7759
Abdominal Pain 2584 2584
Death 2169 2169
No Patient Involvement 1923 1923
Hernia 1203 1203
Dyspnea 660 660
Unspecified Infection 647 647
Hypervolemia 633 633
Cardiac Arrest 467 467
No Information 449 449
Nausea 428 428
Abdominal Distention 412 412
Vomiting 396 396
Insufficient Information 373 373
Myocardial Infarction 372 372
Pain 334 334
Increased Intra-Peritoneal Volume (IIPV) 307 307
Fever 214 214
No Code Available 204 204
Low Blood Pressure/ Hypotension 201 201
Sepsis 201 201
Chest Pain 201 201
Diarrhea 193 193
Overdose 190 190
Discomfort 189 189
Constipation 165 165
Electrolyte Imbalance 159 159
Pneumonia 149 149
High Blood Pressure/ Hypertension 144 144
Pleural Effusion 121 121
Pulmonary Edema 120 120
Congestive Heart Failure 120 120
Confusion/ Disorientation 105 105
Weakness 95 95
Bacterial Infection 90 90
Heart Failure 89 89
Swelling 84 84
Malaise 83 83
Respiratory Failure 80 80
Edema 76 76
Stroke/CVA 72 72
Fungal Infection 69 69
Uremia 61 61
Fatigue 61 61
Hypoglycemia 61 61
Blood Loss 52 52
Swelling/ Edema 49 49
Cardiopulmonary Arrest 49 49
Hyperglycemia 48 48
Chills 48 48
Loss of consciousness 47 47
Fall 47 47
Dehydration 46 46
Dizziness 46 46
Respiratory Distress 45 45
Anemia 42 42
Hypoxia 35 35
Weight Changes 35 35
Urinary Tract Infection 34 34
Cramp(s) 32 32
Seizures 32 32
Syncope 32 32
Hemorrhage/Bleeding 31 31
Injury 30 30
Atrial Fibrillation 29 29
Septic Shock 28 28
Electric Shock 28 28
Hypovolemia 27 27
Abdominal Cramps 26 26
Encephalopathy 26 26
Arrhythmia 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Pericardial Effusion 25 25
Sudden Cardiac Death 22 22
Tachycardia 21 21
Lethargy 20 20
Peritoneal Laceration(s) 19 19
Inflammation 18 18
Heart Failure/Congestive Heart Failure 18 18
Renal Failure 17 17
Cellulitis 15 15
Colostomy 15 15
Complaint, Ill-Defined 14 14
Obstruction/Occlusion 14 14
Hypersensitivity/Allergic reaction 14 14
Infarction, Cerebral 13 13
Chest Tightness/Pressure 13 13
Burning Sensation 12 12
Test Result 12 12
Hematoma 12 12
Perforation 12 12
Angina 11 11
Bowel Perforation 11 11
Convulsion/Seizure 10 10
Chronic Obstructive Pulmonary Disease (COPD) 10 10
Abscess 10 10
Bradycardia 10 10

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 Corp. III Nov-17-2015
6 Baxter Healthcare Corp. II Mar-18-2015
7 Baxter Healthcare Corp. II Feb-02-2015
8 Baxter Healthcare Corp. II Jan-29-2015
9 Baxter Healthcare Corp. II Jan-07-2015
10 Baxter Healthcare Corp. II Jan-07-2015
11 Baxter Healthcare Corporation II Dec-14-2023
12 Baxter Healthcare Corporation II Apr-01-2023
13 Baxter Healthcare Corporation II May-27-2022
14 Baxter Healthcare Corporation II Oct-03-2019
15 Baxter Healthcare Corporation II Feb-20-2019
16 Baxter Healthcare Corporation II Aug-02-2018
17 Baxter Healthcare Corporation II Aug-16-2017
18 Baxter Healthcare Corporation II Jan-19-2017
19 Baxter Healthcare Renal Div II Aug-02-2012
20 Baxter Healthcare Renal Div II Jul-06-2011
21 Baxter Healthcare Renal Div II May-03-2011
22 Baxter Healthcare Renal Div I Mar-01-2010
23 Fresenius Medical Care Holdings, Inc. III Dec-26-2023
24 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
25 Fresenius Medical Care Holdings, Inc. II Nov-07-2020
26 Fresenius Medical Care Holdings, Inc. II Nov-05-2013
27 Fresenius Medical Care Holdings, Inc. II Jul-10-2013
28 Fresenius Medical Care Holdings, Inc. II Feb-11-2013
29 Fresenius Medical Care Holdings, Inc. II Apr-24-2012
30 Fresenius Medical Care Holdings, Inc. II Oct-20-2010
31 Fresenius Medical Care Renal Therapies Group, LLC II Aug-05-2019
32 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
33 Fresenius Medical Care Renal Therapies Group, LLC II Jan-27-2016
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