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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 RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI SANXIN MEDTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXYLESS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 907 907
Leak/Splash 332 332
Air/Gas in Device 277 277
Detachment of Device or Device Component 169 169
Adverse Event Without Identified Device or Use Problem 168 168
Material Puncture/Hole 147 147
Disconnection 67 67
Loose or Intermittent Connection 45 45
Insufficient Information 33 33
Crack 31 31
Contamination /Decontamination Problem 29 29
Connection Problem 23 23
Obstruction of Flow 22 22
Break 20 20
Occlusion Within Device 16 16
Material Deformation 16 16
Air Leak 15 15
Device Dislodged or Dislocated 15 15
Material Separation 13 13
Kinked 11 11
Degraded 10 10
Misconnection 10 10
Detachment Of Device Component 10 10
Defective Component 9 9
Device Operates Differently Than Expected 9 9
Material Split, Cut or Torn 9 9
Separation Problem 8 8
No Fail-Safe Mechanism 8 8
Hole In Material 7 7
Device Contamination with Chemical or Other Material 6 6
Inadequate Filtration Process 6 6
Pressure Problem 6 6
Improper Flow or Infusion 5 5
Material Rupture 5 5
Material Perforation 5 5
Improper or Incorrect Procedure or Method 5 5
Device Displays Incorrect Message 5 5
Migration or Expulsion of Device 5 5
Failure To Adhere Or Bond 5 5
Coagulation in Device or Device Ingredient 4 4
Increase in Pressure 4 4
Device Operational Issue 4 4
Gas/Air Leak 4 4
Component Missing 4 4
Filtration Problem 3 3
Patient-Device Incompatibility 3 3
Split 3 3
Device Alarm System 3 3
Output Problem 3 3
Device Handling Problem 3 3
Torn Material 3 3
Protective Measures Problem 2 2
No Flow 2 2
Material Twisted/Bent 2 2
No Apparent Adverse Event 2 2
Burst Container or Vessel 2 2
No Audible Alarm 2 2
Loss of Power 2 2
Decrease in Pressure 2 2
Device Maintenance Issue 2 2
Defective Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure of Device to Self-Test 2 2
Device Slipped 2 2
Smoking 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Deliver 1 1
Cut In Material 1 1
Structural Problem 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Close 1 1
Inflation Problem 1 1
Decoupling 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Power Conditioning Problem 1 1
Contamination 1 1
Display or Visual Feedback Problem 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Inaccurate Flow Rate 1 1
Circuit Failure 1 1
Complete Blockage 1 1
Defective Alarm 1 1
Partial Blockage 1 1
Incomplete or Inadequate Connection 1 1
Infusion or Flow Problem 1 1
Pumping Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Noise, Audible 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 470 470
Hemorrhage/Bleeding 334 334
Blood Loss 134 134
No Consequences Or Impact To Patient 79 79
Death 63 63
Low Blood Pressure/ Hypotension 55 55
Hemolysis 53 53
Cardiac Arrest 46 46
Loss of consciousness 39 39
Insufficient Information 31 31
Dyspnea 21 21
Chest Pain 18 18
Exsanguination 17 17
Cardiopulmonary Arrest 15 15
Anemia 15 15
Hypovolemia 13 13
Syncope 12 12
Nausea 11 11
Hypersensitivity/Allergic reaction 10 10
Abdominal Pain 9 9
Dizziness 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Patient Involvement 8 8
Vomiting 8 8
No Code Available 7 7
High Blood Pressure/ Hypertension 6 6
Bradycardia 6 6
Air Embolism 5 5
Malaise 5 5
Itching Sensation 5 5
Seizures 5 5
Confusion/ Disorientation 5 5
Diaphoresis 4 4
Low Oxygen Saturation 4 4
Syncope/Fainting 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Pain 4 4
Hypoxia 4 4
Headache 3 3
Fever 3 3
Pulmonary Embolism 3 3
Coagulation Disorder 3 3
Unspecified Infection 3 3
Tachycardia 3 3
Reaction 3 3
Peritonitis 3 3
Chills 3 3
Sudden Cardiac Death 3 3
Shaking/Tremors 3 3
Loss Of Pulse 3 3
Hypervolemia 3 3
Foreign Body In Patient 3 3
Chemical Exposure 2 2
Decreased Respiratory Rate 2 2
Convulsion/Seizure 2 2
Test Result 2 2
Respiratory Distress 2 2
Weakness 2 2
Seizures, Absence 2 2
Hemolytic Anemia 2 2
Anxiety 2 2
Anaphylactoid 2 2
Sepsis 2 2
Shock 2 2
Myocardial Infarction 2 2
Congestive Heart Failure 2 2
Bacterial Infection 2 2
Macular Edema 2 2
Hyperthermia 2 2
Hypoglycemia 1 1
Incontinence 1 1
Hypothermia 1 1
Hypovolemic Shock 1 1
Fainting 1 1
Fistula 1 1
Diarrhea 1 1
Dysphagia/ Odynophagia 1 1
Anaphylactic Shock 1 1
Angina 1 1
Apnea 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Thrombus 1 1
Urinary Retention 1 1
Ventricular Fibrillation 1 1
Blurred Vision 1 1
Inflammation 1 1
Ischemia 1 1
Memory Loss/Impairment 1 1
Rash 1 1
Renal Disease, End Stage 1 1
Convulsion, Clonic 1 1
Convulsion, Tonic 1 1
Coma 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Jaundice 1 1
Electrolyte Imbalance 1 1
Heart Failure 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 ICU Medical, Inc. II Dec-23-2020
5 Nipro Medical Corporation II May-15-2018
6 Nipro Medical Corporation II Jan-08-2016
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