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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 6
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 489 511
2022 462 462

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1393 1415
High Test Results 332 332
High Readings 233 233
Insufficient Information 142 142
Use of Device Problem 116 116
Mechanical Problem 108 108
No Apparent Adverse Event 104 104
Contamination of Device Ingredient or Reagent 101 101
Device Slipped 86 86
Thermal Decomposition of Device 86 86
Temperature Problem 68 68
Incorrect, Inadequate or Imprecise Result or Readings 64 64
Appropriate Term/Code Not Available 49 49
Device Displays Incorrect Message 40 40
Improper or Incorrect Procedure or Method 40 40
Gas/Air Leak 37 37
Unintended Movement 36 36
Excess Flow or Over-Infusion 35 35
Fluid/Blood Leak 30 30
Output Problem 30 30
Patient-Device Incompatibility 30 30
Overheating of Device 28 28
Microbial Contamination 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
Defective Component 16 16
Coagulation in Device or Device Ingredient 16 16
Obstruction of Flow 15 15
Device Ingredient or Reagent Problem 14 14
Infusion or Flow Problem 13 13
Leak/Splash 13 13
Misassembled 13 13
Smoking 11 11
Pressure Problem 10 10
Device Handling Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Defective Device 9 9
Human-Device Interface Problem 9 9
Loose or Intermittent Connection 9 9
Computer Software Problem 9 9
Overfill 8 8
Device Misassembled During Manufacturing /Shipping 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
Contamination /Decontamination Problem 6 6
Improper Flow or Infusion 5 5
Material Integrity Problem 5 5
Patient Device Interaction Problem 5 5
Display or Visual Feedback Problem 5 5
Device Alarm System 5 5
Backflow 5 5
Air Leak 4 4
Disconnection 4 4
False Positive Result 4 4
Unexpected Therapeutic Results 4 4
Noise, Audible 4 4
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 4 4
Connection Problem 3 3
Low Test Results 3 3
Material Twisted/Bent 3 3
Patient Data Problem 3 3
Protective Measures Problem 3 3
Mechanics Altered 3 3
No Flow 3 3
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
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
Loss of Power 2 2
Device Difficult to Setup or Prepare 2 2
Failure to Calibrate 2 2
Failure to Deliver 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
Free or Unrestricted Flow 2 2
Device Sensing Problem 2 2
Expiration Date Error 2 2
Sparking 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 947 947
No Patient Involvement 795 796
No Known Impact Or Consequence To Patient 194 194
Reaction 98 98
Insufficient Information 60 60
Death 58 58
Hypersensitivity/Allergic reaction 35 57
Low Blood Pressure/ Hypotension 35 57
No Consequences Or Impact To Patient 35 35
Hemolysis 26 26
Patient Problem/Medical Problem 26 26
Fever 18 18
Bacterial Infection 16 16
Anemia 14 14
Chest Pain 12 12
Electrolyte Imbalance 12 34
Pain 12 12
Tachycardia 12 12
Nausea 11 11
Cardiac Arrest 11 11
Dizziness 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 32
Loss of consciousness 9 9
Chills 9 9
Dyspnea 9 9
Headache 8 8
Hematoma 8 8
Rash 8 8
No Information 8 8
Local Reaction 7 7
Unspecified Infection 6 28
Tingling 6 6
Vomiting 6 6
Discomfort 6 6
High Blood Pressure/ Hypertension 6 6
Erythema 6 6
Fatigue 6 6
Blood Loss 6 6
Hypervolemia 5 5
No Code Available 5 5
Numbness 5 5
Injury 5 5
Needle Stick/Puncture 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Hemorrhage/Bleeding 5 5
Sepsis 5 5
Itching Sensation 4 4
Thrombocytopenia 4 4
Pallor 4 4
Toxicity 4 4
Anxiety 3 3
Syncope/Fainting 3 3
Diaphoresis 3 3
Test Result 3 3
Vaso-Vagal Response 3 3
Confusion/ Disorientation 3 3
Low White Blood Cell Count 3 3
Cough 3 3
Swelling/ Edema 3 3
Thrombosis 3 3
Hypovolemia 3 3
Stroke/CVA 3 3
Anaphylactic Shock 3 3
Pulmonary Embolism 3 3
Syncope 2 2
Hemoconcentration 2 2
Air Embolism 2 2
Exposure to Body Fluids 2 2
Bradycardia 2 2
Bruise/Contusion 2 2
Viral Infection 2 2
Cramp(s) 2 2
Infiltration into Tissue 2 2
Cardiovascular Insufficiency 2 2
Hematuria 2 2
Ptosis 2 2
Movement Disorder 2 2
Sudden Cardiac Death 2 2
Shaking/Tremors 1 1
Abdominal Cramps 1 1
Nasal Obstruction 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Low Cardiac Output 1 1
Malaise 1 1
Coma 1 1
Fungal Infection 1 1
Sweating 1 1
Convulsion/Seizure 1 1
Lethargy 1 1
Alteration In Body Temperature 1 1
Reaction to Medicinal Component of Device 1 1
Unspecified Blood or Lymphatic problem 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Transient Ischemic Attack 1 1

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