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

MDR Year MDR Reports MDR Events
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 696 696
Air/Gas in Device 277 277
Leak/Splash 274 274
Detachment of Device or Device Component 166 166
Material Puncture/Hole 144 144
Adverse Event Without Identified Device or Use Problem 55 55
Disconnection 37 37
Contamination /Decontamination Problem 29 29
Loose or Intermittent Connection 27 27
Crack 20 20
Obstruction of Flow 20 20
Break 18 18
Material Deformation 16 16
Degraded 10 10
Material Split, Cut or Torn 9 9
Separation Problem 8 8
Defective Component 6 6
Improper or Incorrect Procedure or Method 5 5
Inadequate Filtration Process 5 5
Material Separation 5 5
Device Contamination with Chemical or Other Material 5 5
Connection Problem 5 5
Gas/Air Leak 4 4
No Fail-Safe Mechanism 4 4
Component Missing 4 4
Device Alarm System 3 3
Output Problem 3 3
Pressure Problem 3 3
Improper Flow or Infusion 3 3
Material Twisted/Bent 2 2
Failure of Device to Self-Test 2 2
Defective Device 2 2
Protective Measures Problem 2 2
No Flow 2 2
Material Rupture 2 2
Tear, Rip or Hole in Device Packaging 2 2
No Audible Alarm 2 2
Loss of Power 2 2
Inflation Problem 1 1
Use of Device Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Deliver 1 1
Fitting Problem 1 1
Defective Alarm 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Contamination 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Power Conditioning Problem 1 1
Display or Visual Feedback Problem 1 1
Unintended Ejection 1 1
Inaccurate Flow Rate 1 1
Incomplete or Inadequate Connection 1 1
Pumping Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Patient-Device Incompatibility 1 1
Structural Problem 1 1
Device Dislodged or Dislocated 1 1
Filtration Problem 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 845 845
Hemorrhage/Bleeding 330 330
No Known Impact Or Consequence To Patient 266 266
No Consequences Or Impact To Patient 42 42
Insufficient Information 31 31
Blood Loss 29 29
Low Blood Pressure/ Hypotension 29 29
Hemolysis 18 18
Cardiac Arrest 16 16
Loss of consciousness 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Dizziness 8 8
Anemia 8 8
Exsanguination 8 8
Hypersensitivity/Allergic reaction 6 6
Death 6 6
Dyspnea 6 6
No Patient Involvement 5 5
Low Oxygen Saturation 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Syncope/Fainting 4 4
Chest Pain 4 4
Itching Sensation 4 4
Hypovolemia 4 4
Nausea 3 3
Cardiopulmonary Arrest 3 3
Syncope 3 3
Bradycardia 3 3
No Code Available 3 3
Convulsion/Seizure 2 2
Loss Of Pulse 2 2
Chemical Exposure 2 2
Hypervolemia 2 2
Decreased Respiratory Rate 2 2
Confusion/ Disorientation 2 2
Anxiety 2 2
Malaise 2 2
Congestive Heart Failure 2 2
High Blood Pressure/ Hypertension 2 2
Abdominal Pain 2 2
Air Embolism 2 2
Hypoxia 2 2
Vomiting 2 2
Weakness 1 1
Jaundice 1 1
Peritonitis 1 1
Hemolytic Anemia 1 1
Anaphylactoid 1 1
Convulsion, Tonic 1 1
Pain 1 1
Rash 1 1
Seizures 1 1
Headache 1 1
Hypovolemic Shock 1 1
Angina 1 1
Coagulation Disorder 1 1
Hyperthermia 1 1
Obstruction/Occlusion 1 1
Diaphoresis 1 1
Lethargy 1 1
Sudden Cardiac Death 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Cough 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
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