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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 4
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 235 235
2026 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1245 1268
Insufficient Information 982 983
No Apparent Adverse Event 251 251
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 16 16
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 9 9
Leak/Splash 8 8
Patient-Device Incompatibility 8 8
Excess Flow or Over-Infusion 7 7
Misassembled 7 7
Loose or Intermittent Connection 6 6
Gas/Air Leak 6 6
Overheating of Device 6 6
Device Misassembled During Manufacturing /Shipping 6 6
Computer Software Problem 6 6
Inadequate User Interface 5 5
Patient Device Interaction Problem 5 5
Obstruction of Flow 4 4
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
Mechanics Altered 3 3
Thermal Decomposition of Device 3 3
Improper Flow or Infusion 3 3
Increase in Pressure 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
Defective Component 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 1668 1672
Insufficient Information 78 78
Hypersensitivity/Allergic reaction 41 63
Hemolysis 36 37
Low Blood Pressure/ Hypotension 36 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 51
Hypovolemia 23 23
Bacterial Infection 22 22
Nausea 18 18
Fever 17 17
Local Reaction 16 16
Air Embolism 15 15
Hypervolemia 14 14
Loss of consciousness 14 14
Chest Pain 13 13
Chills 11 11
Hematuria 11 11
Hemorrhage/Bleeding 10 10
Pain 10 10
Cardiac Arrest 10 10
Dizziness 9 9
Headache 9 9
Electrolyte Imbalance 9 31
Sepsis 8 8
Fatigue 7 7
Hematoma 7 7
Dyspnea 7 7
Numbness 7 7
Anemia 7 7
Pallor 7 7
Rash 7 7
Vomiting 6 6
Diaphoresis 6 6
Syncope/Fainting 6 6
Swelling/ Edema 6 6
Discomfort 5 5
Cardiovascular Insufficiency 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Needle Stick/Puncture 5 5
Tachycardia 5 5
High Blood Pressure/ Hypertension 4 4
Anxiety 4 4
Itching Sensation 4 4
Thrombocytopenia 4 4
Cough 3 3
Bruise/Contusion 3 3
Confusion/ Disorientation 3 3
Bradycardia 3 3
Abdominal Pain 3 3
Stroke/CVA 3 3

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