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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
CARIDIANBCT
  SUBSTANTIALLY EQUIVALENT 5
FENWAL INC
  SUBSTANTIALLY EQUIVALENT 12
FENWAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 12
FRESENIUS KABI USA LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI USA LLC.
  SUBSTANTIALLY EQUIVALENT 6
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
HAEMONETICS CORPORATION SOFTWARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
HARVEST TECHNOLOGIES CORP
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT
  SUBSTANTIALLY EQUIVALENT 8
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 10
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 371 371
2015 357 357
2016 440 440
2017 327 327
2018 354 354
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 2112 2134
High Test Results 747 747
Insufficient Information 523 523
Device Operates Differently Than Expected 344 344
High Readings 255 255
No Apparent Adverse Event 163 163
Use of Device Problem 148 148
Mechanical Problem 142 142
Improper or Incorrect Procedure or Method 125 125
Device Slipped 121 121
Contamination of Device Ingredient or Reagent 106 106
Device Displays Incorrect Message 105 105
Appropriate Term/Code Not Available 105 105
Thermal Decomposition of Device 90 90
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Temperature Problem 68 68
Fluid/Blood Leak 65 65
Air Leak 54 54
Patient-Device Incompatibility 49 49
Inadequate User Interface 40 40
Microbial Contamination of Device 39 39
Unintended Movement 39 39
Gas/Air Leak 37 37
Excess Flow or Over-Infusion 37 37
Output Problem 33 33
Component Falling 31 31
Overheating of Device 28 28
Leak/Splash 27 27
Incorrect Or Inadequate Test Results 24 24
Air/Gas in Device 22 22
Data Problem 21 21
Therapeutic or Diagnostic Output Failure 20 20
Defective Component 20 20
Occlusion Within Device 20 20
Coagulation in Device or Device Ingredient 18 18
Device Handling Problem 18 18
Obstruction of Flow 17 17
Infusion or Flow Problem 16 16
Misassembled 15 15
Product Quality Problem 15 15
Smoking 14 14
Device Operational Issue 14 14
Device Ingredient or Reagent Problem 14 14
Computer Software Problem 13 13
Contamination 12 12
Device Alarm System 12 12
Nonstandard Device 12 12
Device Misassembled During Manufacturing /Shipping 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Pressure Problem 12 12
Increase in Pressure 11 11
Complete Blockage 11 11
Disconnection 10 10
Loose or Intermittent Connection 10 10
Human-Device Interface Problem 10 10
Improper Flow or Infusion 10 10
Patient Data Problem 10 10
Defective Device 9 9
Overfill 9 9
Clumping in Device or Device Ingredient 9 9
Backflow 8 8
Device Expiration Issue 8 8
Noise, Audible 8 8
Fire 7 7
Display or Visual Feedback Problem 7 7
Contamination /Decontamination Problem 7 7
Insufficient Flow or Under Infusion 6 6
Positioning Problem 6 6
Material Integrity Problem 6 6
Filtration Problem 6 6
Use of Incorrect Control/Treatment Settings 6 6
Break 6 6
Hole In Material 6 6
Programming Issue 6 6
Protective Measures Problem 5 5
Patient Device Interaction Problem 5 5
Device Difficult to Setup or Prepare 5 5
False Positive Result 5 5
Detachment of Device or Device Component 5 5
Component Missing 5 5
Connection Problem 4 4
Low Test Results 4 4
Device Contamination with Chemical or Other Material 4 4
No Flow 4 4
Partial Blockage 4 4
Decrease in Pressure 4 4
Unintended System Motion 4 4
Loss of Power 4 4
Unexpected Therapeutic Results 4 4
Self-Activation or Keying 3 3
Incorrect Measurement 3 3
Kinked 3 3
Unintended Ejection 3 3
Mechanics Altered 3 3
Material Twisted/Bent 3 3
Device Contamination With Biological Material 3 3
Difficult to Open or Close 3 3
Sparking 3 3
Malposition of Device 2 2
Calibration Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1416 1417
No Clinical Signs, Symptoms or Conditions 1302 1302
No Known Impact Or Consequence To Patient 642 642
Reaction 213 213
No Consequences Or Impact To Patient 101 101
Death 76 76
No Information 76 76
Numbness 70 70
Low Blood Pressure/ Hypotension 63 85
Insufficient Information 63 63
Hemolysis 49 49
Hypersensitivity/Allergic reaction 48 70
Fever 42 42
Nausea 37 37
Tingling 36 36
Bacterial Infection 34 34
Patient Problem/Medical Problem 27 27
No Code Available 25 25
Chills 25 25
Headache 24 24
Vomiting 23 23
Dizziness 22 22
Dyspnea 20 20
Chest Pain 19 19
Pain 19 19
Electrolyte Imbalance 19 41
Hypovolemia 19 19
Loss of consciousness 18 18
Cardiac Arrest 18 18
Tachycardia 17 17
Anemia 16 16
Hematoma 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 38
Blood Loss 14 14
Toxicity 13 13
Exposure to Body Fluids 13 13
Hemorrhage/Bleeding 12 12
Hypervolemia 12 12
Test Result 11 11
Air Embolism 10 10
Needle Stick/Puncture 10 10
Diaphoresis 9 9
Rash 9 9
Local Reaction 8 8
Sepsis 8 8
High Blood Pressure/ Hypertension 8 8
Pallor 8 8
Hematuria 8 8
Urticaria 8 8
Complaint, Ill-Defined 7 7
Injury 7 7
Fungal Infection 7 7
Fatigue 7 7
Bradycardia 6 6
Stroke/CVA 6 6
Unspecified Infection 6 28
Thrombosis 6 6
Shaking/Tremors 6 6
Discomfort 6 6
Seizures 6 6
Confusion/ Disorientation 5 5
Overdose 5 5
Infiltration into Tissue 5 5
Itching Sensation 5 5
Anaphylactic Shock 5 5
Vaso-Vagal Response 5 5
Syncope/Fainting 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Cough 4 4
Thrombocytopenia 4 4
Pulmonary Embolism 4 4
Bruise/Contusion 4 4
Erythema 4 4
Thrombus 4 4
Sweating 4 4
Anxiety 4 4
Malaise 3 3
Cramp(s) 3 3
Weakness 3 3
Transient Ischemic Attack 3 3
Chest Tightness/Pressure 3 3
Septic Shock 3 3
Fungus 3 3
Incontinence 3 3
Fainting 3 3
Low White Blood Cell Count 3 3
Cardiovascular Insufficiency 3 3
Swelling/ Edema 3 3
Thrombosis/Thrombus 2 2
Movement Disorder 2 2
Convulsion/Seizure 2 2
Bone Fracture(s) 2 2
Diarrhea 2 2
Hemoconcentration 2 2
Cardiopulmonary Arrest 2 2
Syncope 2 2
Abdominal Pain 2 2
Muscle Weakness 2 2
Paralysis 2 2
Skin Discoloration 2 2

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