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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
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 434 434
2020 561 561
2021 490 512
2022 446 446
2023 344 344
2024 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1530 1552
Insufficient Information 443 443
High Test Results 335 335
High Readings 221 221
No Apparent Adverse Event 154 154
Mechanical Problem 136 136
Use of Device Problem 116 116
Device Slipped 115 115
Contamination of Device Ingredient or Reagent 102 102
Temperature Problem 68 68
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Thermal Decomposition of Device 54 54
Appropriate Term/Code Not Available 48 48
Gas/Air Leak 34 34
Excess Flow or Over-Infusion 34 34
Output Problem 32 32
Fluid/Blood Leak 31 31
Unintended Movement 31 31
Improper or Incorrect Procedure or Method 29 29
Overheating of Device 28 28
Microbial Contamination of Device 25 25
Device Displays Incorrect Message 24 24
Air/Gas in Device 22 22
Therapeutic or Diagnostic Output Failure 20 20
Patient-Device Incompatibility 19 19
Device Handling Problem 15 15
Device Ingredient or Reagent Problem 14 14
Infusion or Flow Problem 13 13
Misassembled 12 12
Coagulation in Device or Device Ingredient 12 12
Inadequate User Interface 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Leak/Splash 11 11
Smoking 10 10
Obstruction of Flow 9 9
Pressure Problem 9 9
Computer Software Problem 9 9
Loose or Intermittent Connection 9 9
Defective Device 9 9
Overfill 8 8
Contamination /Decontamination Problem 7 7
Increase in Pressure 6 6
Data Problem 6 6
Device Misassembled During Manufacturing /Shipping 6 6
Complete Blockage 5 5
Improper Flow or Infusion 5 5
Display or Visual Feedback Problem 5 5
Device Alarm System 5 5
Backflow 5 5
Defective Component 4 4
Material Integrity Problem 4 4
Contamination 4 4
False Positive Result 4 4
Noise, Audible 4 4
Device Contamination with Chemical or Other Material 4 4
Partial Blockage 3 3
Low Test Results 3 3
Protective Measures Problem 3 3
Patient Device Interaction Problem 3 3
Detachment of Device or Device Component 3 3
Disconnection 3 3
Mechanics Altered 3 3
Unexpected Therapeutic Results 3 3
No Flow 3 3
Component Missing 3 3
No Audible Alarm 2 2
Failure to Calibrate 2 2
Material Puncture/Hole 2 2
Device Difficult to Setup or Prepare 2 2
No Display/Image 2 2
Incorrect Measurement 2 2
Material Split, Cut or Torn 2 2
Connection Problem 2 2
Self-Activation or Keying 2 2
Device Fell 2 2
Clumping in Device or Device Ingredient 2 2
Device Sensing Problem 2 2
Migration 2 2
Material Twisted/Bent 2 2
Fire 2 2
Expiration Date Error 2 2
Positioning Problem 2 2
Free or Unrestricted Flow 2 2
Collapse 2 2
Crack 2 2
Misassembly by Users 2 2
Unexpected Shutdown 2 2
Mechanical Jam 1 1
Component Incompatible 1 1
Use of Incorrect Control/Treatment Settings 1 1
Loss of Power 1 1
Unsealed Device Packaging 1 1
Inadequate or Insufficient Training 1 1
Patient Data Problem 1 1
No Pressure 1 1
Inadequate Filtration Process 1 1
Fitting Problem 1 1
Decrease in Pressure 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1302 1302
No Patient Involvement 567 568
No Known Impact Or Consequence To Patient 112 112
Reaction 81 81
Insufficient Information 63 63
Death 46 46
Hypersensitivity/Allergic reaction 40 62
Low Blood Pressure/ Hypotension 37 59
Hemolysis 27 27
No Consequences Or Impact To Patient 24 24
Patient Problem/Medical Problem 24 24
Fever 22 22
Bacterial Infection 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 38
Hypovolemia 15 15
Tachycardia 14 14
Pain 13 13
Electrolyte Imbalance 13 35
Chest Pain 13 13
Cardiac Arrest 13 13
Dizziness 12 12
Nausea 12 12
Anemia 11 11
Hemorrhage/Bleeding 11 11
Loss of consciousness 11 11
Hypervolemia 10 10
Dyspnea 10 10
Air Embolism 10 10
Chills 9 9
Rash 8 8
Local Reaction 8 8
Sepsis 8 8
Hematuria 8 8
Numbness 7 7
Headache 7 7
Hematoma 7 7
Fatigue 6 6
Unspecified Infection 6 28
Pallor 6 6
Blood Loss 6 6
Diaphoresis 5 5
Needle Stick/Puncture 5 5
Syncope/Fainting 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Discomfort 5 5
Injury 5 5
High Blood Pressure/ Hypertension 5 5
Erythema 4 4
Stroke/CVA 4 4
Vomiting 4 4
Cough 4 4
Confusion/ Disorientation 4 4
No Information 4 4
No Code Available 4 4
Thrombocytopenia 4 4
Low White Blood Cell Count 3 3
Cardiovascular Insufficiency 3 3
Swelling/ Edema 3 3
Anxiety 3 3
Anaphylactic Shock 3 3
Pulmonary Embolism 3 3
Syncope 2 2
Bradycardia 2 2
Bruise/Contusion 2 2
Diarrhea 2 2
Hemoconcentration 2 2
Incontinence 2 2
Brain Injury 2 2
Tingling 2 2
Hot Flashes/Flushes 2 2
Thrombosis 2 2
Tinnitus 2 2
Transient Ischemic Attack 2 2
Itching Sensation 2 2
Thrombosis/Thrombus 2 2
Movement Disorder 2 2
Convulsion/Seizure 2 2
Test Result 2 2
Ptosis 2 2
Vaso-Vagal Response 2 2
Toxicity 2 2
Sudden Cardiac Death 2 2
Respiratory Failure 2 2
Fungal Infection 2 2
Coma 1 1
Nasal Obstruction 1 1
Low Oxygen Saturation 1 1
Increased Respiratory Rate 1 1
Ischemic Heart Disease 1 1
Low Cardiac Output 1 1
Shaking/Tremors 1 1
Abdominal Cramps 1 1
Lethargy 1 1
Unspecified Blood or Lymphatic problem 1 1
Embolism/Embolus 1 1
Paresthesia 1 1
Respiratory Insufficiency 1 1
Renal Impairment 1 1
Increased Sensitivity 1 1
Reaction to Medicinal Component of Device 1 1

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