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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
Regulation Description Automated blood cell separator.
Product CodeGKT
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 5
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TERUMO BCT
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 490 514
2022 445 447
2023 343 343
2024 444 444
2025 233 233
2026 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1266 1289
Insufficient Information 998 999
No Apparent Adverse Event 259 259
High Test Results 149 149
Mechanical Problem 120 120
Use of Device Problem 111 111
Device Slipped 106 106
Contamination of Device Ingredient or Reagent 102 102
High Readings 72 72
Temperature Problem 67 67
Device Handling Problem 67 67
Output Problem 31 31
Fluid/Blood Leak 21 23
Air/Gas in Device 21 21
Appropriate Term/Code Not Available 17 17
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Unintended Movement 13 13
Microbial Contamination of Device 12 12
Infusion or Flow Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Improper or Incorrect Procedure or Method 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Leak/Splash 8 8
Patient-Device Incompatibility 8 8
Excess Flow or Over-Infusion 7 7
Misassembled 7 7
Gas/Air Leak 6 6
Loose or Intermittent Connection 6 6
Device Misassembled During Manufacturing /Shipping 6 6
Overheating of Device 6 6
Computer Software Problem 6 6
Patient Device Interaction Problem 5 5
Defective Component 5 5
Inadequate User Interface 5 5
Material Integrity Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Device Alarm System 4 4
Display or Visual Feedback Problem 4 4
Obstruction of Flow 4 4
Mechanics Altered 3 3
Increase in Pressure 3 3
Thermal Decomposition of Device 3 3
Improper Flow or Infusion 3 3
Unexpected Therapeutic Results 3 3
False Positive Result 3 3
Device Displays Incorrect Message 3 3
Contamination /Decontamination Problem 3 3
Defective Device 3 3
Crack 3 3
Component Missing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1678 1682
Insufficient Information 81 81
Hypersensitivity/Allergic reaction 41 63
Hemolysis 41 42
Low Blood Pressure/ Hypotension 35 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 52
Hypovolemia 23 23
Bacterial Infection 22 22
Fever 18 18
Nausea 18 18
Air Embolism 15 15
Loss of consciousness 15 15
Local Reaction 15 15
Hypervolemia 14 14
Chills 13 13
Chest Pain 13 13
Hematuria 11 11
Hemorrhage/Bleeding 10 10
Cardiac Arrest 10 10
Pain 10 10
Headache 9 9
Electrolyte Imbalance 9 31
Dizziness 9 9
Sepsis 8 8
Vomiting 8 8
Pallor 7 7
Rash 7 7
Numbness 7 7
Dyspnea 7 7
Anemia 7 7
Hematoma 7 7
Fatigue 7 7
Syncope/Fainting 7 7
Swelling/ Edema 6 6
Diaphoresis 6 6
Tachycardia 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Cardiovascular Insufficiency 5 5
Discomfort 5 5
Needle Stick/Puncture 5 5
Itching Sensation 4 4
Anxiety 4 4
Thrombocytopenia 4 4
High Blood Pressure/ Hypertension 4 4
Bradycardia 3 3
Cough 3 3
Hot Flashes/Flushes 3 3
Bruise/Contusion 3 3
Exposure to Body Fluids 3 3
Abdominal Pain 3 3

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