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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, tubing, blood, with and without anti-regurgitation valve
Product CodeFJK
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIMESOL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO RENAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOME DIALYSIS PLUS
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI SANXIN MEDTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXYLESS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 113 113
2015 126 126
2016 139 139
2017 131 131
2018 119 119
2019 185 185
2020 190 190
2021 188 188
2022 362 362
2023 585 585
2024 119 119

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 936 936
Leak/Splash 334 334
Air/Gas in Device 277 277
Adverse Event Without Identified Device or Use Problem 205 205
Detachment of Device or Device Component 169 169
Material Puncture/Hole 147 147
Disconnection 79 79
Insufficient Information 49 49
Loose or Intermittent Connection 46 46
Crack 35 35
Contamination /Decontamination Problem 29 29
Connection Problem 27 27
Air Leak 24 24
Obstruction of Flow 22 22
Break 20 20
Occlusion Within Device 17 17
Material Separation 16 16
Material Deformation 16 16
Detachment Of Device Component 16 16
Device Dislodged or Dislocated 15 15
Device Operates Differently Than Expected 12 12
Misconnection 11 11
Kinked 11 11
Degraded 10 10
Material Split, Cut or Torn 9 9
Defective Component 9 9
Separation Problem 8 8
No Fail-Safe Mechanism 8 8
Hole In Material 8 8
Device Displays Incorrect Message 7 7
Device Contamination with Chemical or Other Material 6 6
Inadequate Filtration Process 6 6
Pressure Problem 6 6
Improper Flow or Infusion 6 6
Material Rupture 6 6
Material Perforation 5 5
Improper or Incorrect Procedure or Method 5 5
Failure To Adhere Or Bond 5 5
Migration or Expulsion of Device 5 5
Device Operational Issue 4 4
Gas/Air Leak 4 4
Increase in Pressure 4 4
Coagulation in Device or Device Ingredient 4 4
Component Missing 4 4
Device Alarm System 4 4
Split 3 3
Torn Material 3 3
Filtration Problem 3 3
Output Problem 3 3
Device Handling Problem 3 3
Use of Device Problem 3 3
Patient-Device Incompatibility 3 3
Material Twisted/Bent 2 2
Burst Container or Vessel 2 2
Tear, Rip or Hole in Device Packaging 2 2
No Audible Alarm 2 2
No Flow 2 2
No Apparent Adverse Event 2 2
Protective Measures Problem 2 2
Loss of Power 2 2
Failure of Device to Self-Test 2 2
Device Maintenance Issue 2 2
Decrease in Pressure 2 2
Device Slipped 2 2
Defective Device 2 2
Nonstandard Device 1 1
Noise, Audible 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Cut In Material 1 1
Filling Problem 1 1
Temperature Problem 1 1
Display or Visual Feedback Problem 1 1
Defective Alarm 1 1
Alarm Not Visible 1 1
Partial Blockage 1 1
Unintended Movement 1 1
Fitting Problem 1 1
Incomplete or Inadequate Connection 1 1
Complete Blockage 1 1
Device Damaged by Another Device 1 1
Pumping Problem 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Suction Problem 1 1
Unintended Ejection 1 1
Deflation Problem 1 1
Failure to Deliver 1 1
Appropriate Term/Code Not Available 1 1
Smoking 1 1
Circuit Failure 1 1
Delivered as Unsterile Product 1 1
Decoupling 1 1
Inaccurate Flow Rate 1 1
Material Integrity Problem 1 1
Contamination 1 1
Device Contamination with Body Fluid 1 1
Power Conditioning Problem 1 1
Infusion or Flow Problem 1 1
Inflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 845 845
No Known Impact Or Consequence To Patient 513 513
Hemorrhage/Bleeding 334 334
Blood Loss 160 160
Death 82 82
No Consequences Or Impact To Patient 79 79
Low Blood Pressure/ Hypotension 62 62
Hemolysis 55 55
Cardiac Arrest 52 52
Loss of consciousness 39 39
Cardiopulmonary Arrest 35 35
Insufficient Information 31 31
Dyspnea 22 22
Exsanguination 18 18
Chest Pain 18 18
Anemia 15 15
Syncope 13 13
Hypovolemia 13 13
Nausea 11 11
Abdominal Pain 11 11
Hypersensitivity/Allergic reaction 10 10
Bradycardia 9 9
Dizziness 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Code Available 8 8
No Patient Involvement 8 8
Vomiting 8 8
High Blood Pressure/ Hypertension 7 7
Loss Of Pulse 7 7
Air Embolism 6 6
Myocardial Infarction 6 6
Itching Sensation 5 5
Hypoxia 5 5
Seizures 5 5
Confusion/ Disorientation 5 5
Malaise 5 5
Diaphoresis 5 5
Low Oxygen Saturation 4 4
Hypervolemia 4 4
Syncope/Fainting 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Peritonitis 4 4
Pain 4 4
Tachycardia 4 4
Headache 4 4
Fever 3 3
Arrhythmia 3 3
Coagulation Disorder 3 3
Pulmonary Embolism 3 3
Unspecified Infection 3 3
Chills 3 3
Foreign Body In Patient 3 3
Respiratory Failure 3 3
Sudden Cardiac Death 3 3
Shaking/Tremors 3 3
Reaction 3 3
Anxiety 3 3
Decreased Respiratory Rate 2 2
Chemical Exposure 2 2
Convulsion/Seizure 2 2
Test Result 2 2
No Information 2 2
Respiratory Distress 2 2
Sepsis 2 2
Shock 2 2
Weakness 2 2
Seizures, Absence 2 2
Hemolytic Anemia 2 2
Anaphylactoid 2 2
Bacterial Infection 2 2
Congestive Heart Failure 2 2
Macular Edema 2 2
Encephalopathy 2 2
Hyperthermia 2 2
Hypoglycemia 1 1
Hypothermia 1 1
Hypovolemic Shock 1 1
Edema 1 1
Fistula 1 1
Fainting 1 1
Diarrhea 1 1
Dysphagia/ Odynophagia 1 1
Aspiration/Inhalation 1 1
Atrial Tachycardia 1 1
Angina 1 1
Apnea 1 1
Anaphylactic Shock 1 1
Convulsion, Clonic 1 1
Convulsion, Tonic 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Jaundice 1 1
Electrolyte Imbalance 1 1
Inflammation 1 1
Ischemia 1 1
Incontinence 1 1
Memory Loss/Impairment 1 1
Thrombus 1 1
Urinary Retention 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II May-26-2021
2 Baxter Healthcare Corporation II Feb-16-2021
3 Baxter Healthcare Corporation II Jun-01-2020
4 Fresenius Medical Care Holdings, Inc. I Jan-10-2011
5 Gambro Renal Products, Incorporated II Apr-11-2014
6 ICU Medical, Inc. II Dec-23-2020
7 Nipro Medical Corporation II May-15-2018
8 Nipro Medical Corporation II Jan-08-2016
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