Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 269 269

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2258 2280
High Test Results 747 747
Insufficient Information 681 681
Device Operates Differently Than Expected 344 344
High Readings 255 255
No Apparent Adverse Event 213 213
Use of Device Problem 149 149
Mechanical Problem 147 147
Device Slipped 128 128
Improper or Incorrect Procedure or Method 125 125
Appropriate Term/Code Not Available 106 106
Contamination of Device Ingredient or Reagent 106 106
Device Displays Incorrect Message 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 41 41
Unintended Movement 39 39
Microbial Contamination of Device 39 39
Excess Flow or Over-Infusion 38 38
Gas/Air Leak 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
Occlusion Within Device 20 20
Therapeutic or Diagnostic Output Failure 20 20
Defective Component 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
Product Quality Problem 15 15
Misassembled 15 15
Device Operational Issue 14 14
Device Misassembled During Manufacturing /Shipping 14 14
Device Ingredient or Reagent Problem 14 14
Smoking 14 14
Computer Software Problem 13 13
Contamination 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Device Alarm System 12 12
Nonstandard Device 12 12
Pressure Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1465 1465
No Patient Involvement 1416 1417
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
Low Blood Pressure/ Hypotension 72 94
Numbness 71 71
Insufficient Information 66 66
Hemolysis 51 51
Hypersensitivity/Allergic reaction 48 70
Fever 45 45
Nausea 38 38
Tingling 36 36
Bacterial Infection 35 35
Chills 28 28
Patient Problem/Medical Problem 27 27
Hypovolemia 26 26
No Code Available 25 25
Headache 24 24
Vomiting 24 24
Dizziness 23 23
Tachycardia 22 22
Dyspnea 21 21
Loss of consciousness 20 20
Chest Pain 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 41
Pain 19 19
Electrolyte Imbalance 19 41
Cardiac Arrest 19 19
Hematoma 18 18
Hypervolemia 17 17
Anemia 17 17
Local Reaction 15 15
Blood Loss 14 14
Toxicity 13 13
Exposure to Body Fluids 13 13
Hemorrhage/Bleeding 12 12
Air Embolism 11 11
Test Result 11 11
Needle Stick/Puncture 10 10
Rash 10 10
High Blood Pressure/ Hypertension 9 9
Urticaria 9 9
Diaphoresis 9 9
Hematuria 8 8
Pallor 8 8
Sepsis 8 8
Syncope/Fainting 7 7

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