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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 5
FRESENIUS KABI USA LLC.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1498 1520
Insufficient Information 385 385
High Test Results 335 335
High Readings 221 221
No Apparent Adverse Event 148 148
Mechanical Problem 135 135
Device Slipped 114 114
Use of Device Problem 111 111
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
Unintended Movement 31 31
Fluid/Blood Leak 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 Ingredient or Reagent Problem 14 14
Infusion or Flow Problem 13 13
Device Handling Problem 13 13
Inadequate User Interface 12 12
Misassembled 12 12
Coagulation in Device or Device Ingredient 12 12
Leak/Splash 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Smoking 10 10
Defective Device 9 9
Obstruction of Flow 9 9
Loose or Intermittent Connection 9 9
Computer Software Problem 9 9
Pressure Problem 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
Improper Flow or Infusion 5 5
Display or Visual Feedback Problem 5 5
Complete Blockage 5 5
Device Alarm System 5 5
Backflow 5 5
False Positive Result 4 4
Contamination 4 4
Defective Component 4 4
Material Integrity Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Noise, Audible 4 4
Patient Device Interaction Problem 3 3
Detachment of Device or Device Component 3 3
Protective Measures Problem 3 3
Mechanics Altered 3 3
No Flow 3 3
Low Test Results 3 3
Unexpected Therapeutic Results 3 3
Component Missing 3 3
Partial Blockage 3 3
Disconnection 3 3
No Display/Image 2 2
Incorrect Measurement 2 2
Device Difficult to Setup or Prepare 2 2
No Audible Alarm 2 2
Clumping in Device or Device Ingredient 2 2
Collapse 2 2
Fire 2 2
Material Puncture/Hole 2 2
Self-Activation or Keying 2 2
Expiration Date Error 2 2
Crack 2 2
Failure to Calibrate 2 2
Connection Problem 2 2
Positioning Problem 2 2
Misassembly by Users 2 2
Free or Unrestricted Flow 2 2
Device Sensing Problem 2 2
Material Twisted/Bent 2 2
Migration 2 2
Device Fell 2 2
Unexpected Shutdown 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 1 1
Program or Algorithm Execution Failure 1 1
Incomplete or Inadequate Connection 1 1
Incomplete or Inadequate Priming 1 1
Component Misassembled 1 1
Mechanical Jam 1 1
Material Deformation 1 1
Human-Device Interface Problem 1 1
Improper Chemical Reaction 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1255 1255
No Patient Involvement 567 568
No Known Impact Or Consequence To Patient 112 112
Reaction 81 81
Insufficient Information 61 61
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 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 38
Tachycardia 14 14
Pain 13 13
Electrolyte Imbalance 13 35
Chest Pain 13 13
Dizziness 12 12
Nausea 12 12
Cardiac Arrest 11 11
Anemia 11 11
Loss of consciousness 11 11
Hemorrhage/Bleeding 10 10
Dyspnea 10 10
Hypovolemia 10 10
Chills 9 9
Rash 8 8
Sepsis 8 8
Hematuria 8 8
Numbness 7 7
Local Reaction 7 7
Headache 7 7
Hematoma 6 6
Fatigue 6 6
Air Embolism 6 6
Unspecified Infection 6 28
Pallor 6 6
Blood Loss 6 6
Hypervolemia 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
Vaso-Vagal Response 2 2
Ptosis 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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