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TPLC
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show TPLC since
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2024
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Device
separator, automated, blood cell, diagnostic
Product Code
GKT
Regulation Number
864.9245
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Contamination of Device Ingredient or Reagent
106
106
Appropriate Term/Code Not Available
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
Device Handling Problem
18
18
Coagulation in Device or Device Ingredient
18
18
Obstruction of Flow
17
17
Infusion or Flow Problem
16
16
Misassembled
15
15
Product Quality Problem
15
15
Device Misassembled During Manufacturing /Shipping
14
14
Device Ingredient or Reagent Problem
14
14
Smoking
14
14
Device Operational Issue
14
14
Computer Software Problem
13
13
Nonstandard Device
12
12
Manufacturing, Packaging or Shipping Problem
12
12
Pressure Problem
12
12
Contamination
12
12
Device Alarm System
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
Vomiting
24
24
Headache
24
24
Dizziness
23
23
Tachycardia
22
22
Dyspnea
21
21
Chest Pain
20
20
Loss of consciousness
20
20
Pain
19
19
Cardiac Arrest
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
41
Electrolyte Imbalance
19
41
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
Test Result
11
11
Air Embolism
11
11
Needle Stick/Puncture
10
10
Rash
10
10
Diaphoresis
9
9
High Blood Pressure/ Hypertension
9
9
Urticaria
9
9
Sepsis
8
8
Pallor
8
8
Hematuria
8
8
Fatigue
7
7
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Apr-02-2021
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