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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device separator, automated, blood cell, diagnostic
Product CodeGKT
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
FENWAL INC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 7
FRESENIUS KABI USA LLC.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2018 354 354
2019 434 434
2020 561 561
2021 490 512
2022 462 462
2023 158 158

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1561 1583
High Test Results 340 340
Insufficient Information 250 250
High Readings 234 234
No Apparent Adverse Event 131 131
Use of Device Problem 122 122
Mechanical Problem 117 117
Contamination of Device Ingredient or Reagent 106 106
Device Slipped 92 92
Thermal Decomposition of Device 86 86
Temperature Problem 68 68
Incorrect, Inadequate or Imprecise Result or Readings 65 65
Appropriate Term/Code Not Available 49 49
Device Displays Incorrect Message 41 41
Improper or Incorrect Procedure or Method 40 40
Gas/Air Leak 37 37
Unintended Movement 36 36
Excess Flow or Over-Infusion 36 36
Fluid/Blood Leak 35 35
Output Problem 31 31
Patient-Device Incompatibility 30 30
Microbial Contamination of Device 29 29
Overheating of Device 28 28
Air/Gas in Device 22 22
Therapeutic or Diagnostic Output Failure 20 20
Inadequate User Interface 20 20
Device Operates Differently Than Expected 17 17
Coagulation in Device or Device Ingredient 17 17
Defective Component 16 16
Obstruction of Flow 15 15
Leak/Splash 15 15
Misassembled 14 14
Infusion or Flow Problem 14 14
Device Ingredient or Reagent Problem 14 14
Device Handling Problem 11 11
Smoking 11 11
Pressure Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Defective Device 9 9
Human-Device Interface Problem 9 9
Loose or Intermittent Connection 9 9
Computer Software Problem 9 9
Device Misassembled During Manufacturing /Shipping 8 8
Overfill 8 8
Contamination /Decontamination Problem 7 7
Data Problem 7 7
Complete Blockage 7 7
Increase in Pressure 7 7
Clumping in Device or Device Ingredient 6 6
Component Falling 6 6
Contamination 6 6
Display or Visual Feedback Problem 5 5
Device Alarm System 5 5
Backflow 5 5
Patient Device Interaction Problem 5 5
Improper Flow or Infusion 5 5
Material Integrity Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 4 4
Noise, Audible 4 4
Air Leak 4 4
Disconnection 4 4
False Positive Result 4 4
Unexpected Therapeutic Results 4 4
Decrease in Pressure 3 3
Component Missing 3 3
Self-Activation or Keying 3 3
Occlusion Within Device 3 3
Unintended System Motion 3 3
Fire 3 3
Partial Blockage 3 3
Break 3 3
Patient Data Problem 3 3
Protective Measures Problem 3 3
Mechanics Altered 3 3
No Flow 3 3
Connection Problem 3 3
Low Test Results 3 3
Material Twisted/Bent 3 3
Free or Unrestricted Flow 2 2
Device Sensing Problem 2 2
Expiration Date Error 2 2
Sparking 2 2
No Pressure 2 2
Positioning Problem 2 2
Misassembly by Users 2 2
Migration 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Unexpected Shutdown 2 2
Incomplete or Inadequate Connection 2 2
No Audible Alarm 2 2
Collapse 2 2
Hole In Material 2 2
No Display/Image 2 2
Crack 2 2
Incorrect Measurement 2 2
Material Puncture/Hole 2 2
Loss of Power 2 2
Device Difficult to Setup or Prepare 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1072 1072
No Patient Involvement 795 796
No Known Impact Or Consequence To Patient 194 194
Reaction 98 98
Insufficient Information 63 63
Death 58 58
Hypersensitivity/Allergic reaction 39 61
Low Blood Pressure/ Hypotension 39 61
No Consequences Or Impact To Patient 35 35
Hemolysis 28 28
Patient Problem/Medical Problem 26 26
Bacterial Infection 24 24
Fever 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 37
Anemia 14 14
Electrolyte Imbalance 14 36
Nausea 13 13
Tachycardia 13 13
Chest Pain 13 13
Pain 12 12
Dizziness 11 11
Cardiac Arrest 11 11
Dyspnea 10 10
Chills 10 10
Loss of consciousness 10 10
No Information 8 8
Hypervolemia 8 8
Vomiting 8 8
Rash 8 8
Headache 8 8
Hematoma 8 8
Hemorrhage/Bleeding 8 8
Local Reaction 7 7
Unspecified Infection 6 28
Sepsis 6 6
Tingling 6 6
Discomfort 6 6
High Blood Pressure/ Hypertension 6 6
Erythema 6 6
Fatigue 6 6
Blood Loss 6 6
Numbness 6 6
Injury 5 5
Needle Stick/Puncture 5 5
No Code Available 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Cough 4 4
Thrombocytopenia 4 4
Pallor 4 4
Toxicity 4 4
Diaphoresis 4 4
Stroke/CVA 4 4
Itching Sensation 4 4
Thrombosis 3 3
Anxiety 3 3
Hypovolemia 3 3
Diarrhea 3 3
Pulmonary Embolism 3 3
Air Embolism 3 3
Anaphylactic Shock 3 3
Low White Blood Cell Count 3 3
Test Result 3 3
Confusion/ Disorientation 3 3
Vaso-Vagal Response 3 3
Swelling/ Edema 3 3
Syncope/Fainting 3 3
Movement Disorder 2 2
Cardiovascular Insufficiency 2 2
Hematuria 2 2
Ptosis 2 2
Fungal Infection 2 2
Sudden Cardiac Death 2 2
Syncope 2 2
Exposure to Body Fluids 2 2
Bradycardia 2 2
Bruise/Contusion 2 2
Hemoconcentration 2 2
Viral Infection 2 2
Cramp(s) 2 2
Infiltration into Tissue 2 2
Muscle Weakness 1 1
Myocardial Infarction 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Transient Ischemic Attack 1 1
Venipuncture 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Paralysis 1 1
Hot Flashes/Flushes 1 1
Immunodeficiency 1 1
Anaphylactoid 1 1
Brain Injury 1 1
Stenosis 1 1
Therapeutic Response, Decreased 1 1
Complaint, Ill-Defined 1 1
Cardiopulmonary Arrest 1 1
Crushing Injury 1 1
Cyanosis 1 1
Abdominal Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fenwal Inc II Apr-02-2021
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