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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
JIANGXI SANXIN MEDTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OUTSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 131 131
2018 118 118
2019 185 185
2020 190 190
2021 188 188
2022 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 551 551
Leak/Splash 114 114
Detachment of Device or Device Component 71 71
Adverse Event Without Identified Device or Use Problem 68 68
Disconnection 51 51
Contamination /Decontamination Problem 17 17
Crack 17 17
Material Puncture/Hole 17 17
Loose or Intermittent Connection 14 14
Break 13 13
Air Leak 10 10
Connection Problem 9 9
Material Separation 8 8
Air/Gas in Device 7 7
Separation Problem 7 7
Insufficient Information 7 7
No Fail-Safe Mechanism 6 6
Device Dislodged or Dislocated 6 6
Material Split, Cut or Torn 5 5
Obstruction of Flow 5 5
Hole In Material 5 5
Defective Component 4 4
Inadequate Filtration Process 4 4
Device Contamination with Chemical or Other Material 4 4
Improper or Incorrect Procedure or Method 4 4
Occlusion Within Device 4 4
Device Displays Incorrect Message 4 4
Material Rupture 3 3
Material Perforation 3 3
Device Operates Differently Than Expected 3 3
Gas Leak 3 3
Migration or Expulsion of Device 3 3
Loss of Power 2 2
Device Operational Issue 2 2
Burst Container or Vessel 2 2
Failure To Adhere Or Bond 2 2
Detachment Of Device Component 2 2
Component Missing 2 2
Split 2 2
Defective Device 2 2
Device Slipped 2 2
Degraded 2 2
Coagulation in Device or Device Ingredient 2 2
Device Alarm System 1 1
Kinked 1 1
Increase in Pressure 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Smoking 1 1
Use of Device Problem 1 1
Cut In Material 1 1
Nonstandard Device 1 1
Torn Material 1 1
Improper Flow or Infusion 1 1
Difficult to Open or Close 1 1
Inaccurate Flow Rate 1 1
Partial Blockage 1 1
Fitting Problem 1 1
Misconnection 1 1
Power Conditioning Problem 1 1
Material Deformation 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Incomplete or Inadequate Connection 1 1
Complete Blockage 1 1
Inflation Problem 1 1
Device Damaged by Another Device 1 1
Material Twisted/Bent 1 1
Pumping Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 379 379
No Clinical Signs, Symptoms or Conditions 232 232
Blood Loss 82 82
No Consequences Or Impact To Patient 72 72
Hemolysis 31 31
Death 25 25
Low Blood Pressure/ Hypotension 23 23
Cardiac Arrest 20 20
Loss of consciousness 18 18
Dyspnea 14 14
Exsanguination 13 13
Hemorrhage/Bleeding 13 13
Insufficient Information 13 13
Hypovolemia 12 12
Cardiopulmonary Arrest 12 12
Anemia 11 11
Chest Pain 10 10
No Patient Involvement 8 8
Syncope 5 5
Hypersensitivity/Allergic reaction 4 4
Nausea 4 4
No Code Available 4 4
Dizziness 4 4
Diaphoresis 3 3
Foreign Body In Patient 3 3
Confusion/ Disorientation 3 3
Vomiting 3 3
Abdominal Pain 3 3
Congestive Heart Failure 2 2
Weakness 2 2
Seizures 2 2
High Blood Pressure/ Hypertension 2 2
Hyperthermia 2 2
Unspecified Infection 2 2
Decreased Respiratory Rate 2 2
Sudden Cardiac Death 2 2
Hypervolemia 2 2
Loss Of Pulse 2 2
Chemical Exposure 2 2
Convulsion/Seizure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Low Oxygen Saturation 2 2
Hemolytic Anemia 2 2
Anxiety 2 2
Malaise 1 1
Reaction 1 1
Coma 1 1
Respiratory Failure 1 1
Pulmonary Embolism 1 1
Peritonitis 1 1
Anaphylactoid 1 1
Convulsion, Clonic 1 1
Convulsion, Tonic 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
Lethargy 1 1
Itching Sensation 1 1
Myocardial Infarction 1 1
Hypothermia 1 1
Hypovolemic Shock 1 1
Thrombus 1 1
Pain 1 1
Rash 1 1
Respiratory Distress 1 1
Fainting 1 1
Headache 1 1
Air Embolism 1 1
Anaphylactic Shock 1 1
Angina 1 1
Apnea 1 1
Bradycardia 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
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