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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 202 202

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 720 720
Leak/Splash 315 315
Air/Gas in Device 282 282
Detachment of Device or Device Component 172 172
Material Puncture/Hole 153 153
Adverse Event Without Identified Device or Use Problem 59 59
Disconnection 37 37
Contamination /Decontamination Problem 29 29
Loose or Intermittent Connection 27 27
Crack 23 23
Obstruction of Flow 21 21
Break 18 18
Material Deformation 16 16
Degraded 10 10
Separation Problem 9 9
Material Split, Cut or Torn 9 9
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 883 883
Hemorrhage/Bleeding 369 369
No Known Impact Or Consequence To Patient 266 266
No Consequences Or Impact To Patient 42 42
Insufficient Information 33 33
Low Blood Pressure/ Hypotension 30 30
Blood Loss 29 29
Cardiac Arrest 18 18
Hemolysis 18 18
Loss of consciousness 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Exsanguination 8 8
Anemia 8 8
Dizziness 8 8
Hypersensitivity/Allergic reaction 6 6
Death 6 6
Dyspnea 6 6
No Patient Involvement 5 5
Low Oxygen Saturation 4 4
Hypovolemia 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Syncope/Fainting 4 4
Chest Pain 4 4
High Blood Pressure/ Hypertension 4 4
Itching Sensation 4 4
Nausea 3 3
Syncope 3 3
Cardiopulmonary Arrest 3 3
Bradycardia 3 3
No Code Available 3 3
Convulsion/Seizure 2 2
Anxiety 2 2
Malaise 2 2
Decreased Respiratory Rate 2 2
Hypervolemia 2 2
Confusion/ Disorientation 2 2
Loss Of Pulse 2 2
Chemical Exposure 2 2
Abdominal Pain 2 2
Air Embolism 2 2
Congestive Heart Failure 2 2
Hypoxia 2 2
Vomiting 2 2
Weakness 1 1
Jaundice 1 1
Hypovolemic Shock 1 1
Anaphylactoid 1 1
Convulsion, Tonic 1 1
Pain 1 1
Rash 1 1
Seizures 1 1
Hyperthermia 1 1
Headache 1 1
Coagulation Disorder 1 1
Angina 1 1
Pulmonary Embolism 1 1
Lethargy 1 1
Foreign Body In Patient 1 1
Sudden Cardiac Death 1 1
Obstruction/Occlusion 1 1
Diaphoresis 1 1
Peritonitis 1 1
Hemolytic Anemia 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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