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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 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 666 666
Air/Gas in Device 273 273
Leak/Splash 260 260
Detachment of Device or Device Component 161 161
Material Puncture/Hole 127 127
Adverse Event Without Identified Device or Use Problem 51 51
Disconnection 36 36
Contamination /Decontamination Problem 28 28
Loose or Intermittent Connection 27 27
Obstruction of Flow 20 20
Crack 19 19
Break 17 17
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
Gas/Air Leak 4 4
Connection Problem 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 823 823
Hemorrhage/Bleeding 289 289
No Known Impact Or Consequence To Patient 266 266
No Consequences Or Impact To Patient 42 42
Blood Loss 29 29
Low Blood Pressure/ Hypotension 27 27
Insufficient Information 25 25
Hemolysis 18 18
Cardiac Arrest 13 13
Loss of consciousness 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Exsanguination 8 8
Anemia 7 7
Dizziness 7 7
Hypersensitivity/Allergic reaction 6 6
Death 6 6
Dyspnea 6 6
No Patient Involvement 5 5
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
Cramp(s) /Muscle Spasm(s) 3 3
No Code Available 3 3
Convulsion/Seizure 2 2
Loss Of Pulse 2 2
Chemical Exposure 2 2
Hypervolemia 2 2
Anxiety 2 2
Malaise 2 2
Low Oxygen Saturation 2 2
Decreased Respiratory Rate 2 2
Confusion/ Disorientation 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
Lethargy 1 1
Sudden Cardiac Death 1 1
Obstruction/Occlusion 1 1
Diaphoresis 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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