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TPLC
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show TPLC since
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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
1. BK100059
Automated Blood Cell Separators
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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