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TPLC
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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
FENWAL INC
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
5
FRESENIUS KABI USA LLC.
SUBSTANTIALLY EQUIVALENT
1
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
TERUMO BCT
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT, INC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
434
434
2020
561
561
2021
490
512
2022
446
446
2023
344
344
2024
53
53
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1514
1536
Insufficient Information
410
410
High Test Results
335
335
High Readings
221
221
No Apparent Adverse Event
149
149
Mechanical Problem
135
135
Device Slipped
114
114
Use of Device Problem
112
112
Contamination of Device Ingredient or Reagent
102
102
Temperature Problem
68
68
Incorrect, Inadequate or Imprecise Result or Readings
60
60
Thermal Decomposition of Device
54
54
Appropriate Term/Code Not Available
48
48
Gas/Air Leak
34
34
Excess Flow or Over-Infusion
34
34
Output Problem
32
32
Unintended Movement
31
31
Fluid/Blood Leak
31
31
Improper or Incorrect Procedure or Method
29
29
Overheating of Device
28
28
Microbial Contamination of Device
25
25
Device Displays Incorrect Message
24
24
Air/Gas in Device
22
22
Therapeutic or Diagnostic Output Failure
20
20
Patient-Device Incompatibility
19
19
Device Ingredient or Reagent Problem
14
14
Infusion or Flow Problem
13
13
Device Handling Problem
13
13
Inadequate User Interface
12
12
Misassembled
12
12
Coagulation in Device or Device Ingredient
12
12
Leak/Splash
11
11
Manufacturing, Packaging or Shipping Problem
11
11
Smoking
10
10
Defective Device
9
9
Obstruction of Flow
9
9
Loose or Intermittent Connection
9
9
Computer Software Problem
9
9
Pressure Problem
9
9
Overfill
8
8
Contamination /Decontamination Problem
7
7
Increase in Pressure
6
6
Data Problem
6
6
Device Misassembled During Manufacturing /Shipping
6
6
Improper Flow or Infusion
5
5
Display or Visual Feedback Problem
5
5
Complete Blockage
5
5
Device Alarm System
5
5
Backflow
5
5
False Positive Result
4
4
Contamination
4
4
Defective Component
4
4
Material Integrity Problem
4
4
Device Contamination with Chemical or Other Material
4
4
Noise, Audible
4
4
Patient Device Interaction Problem
3
3
Detachment of Device or Device Component
3
3
Protective Measures Problem
3
3
Mechanics Altered
3
3
No Flow
3
3
Low Test Results
3
3
Unexpected Therapeutic Results
3
3
Component Missing
3
3
Partial Blockage
3
3
Disconnection
3
3
No Display/Image
2
2
Incorrect Measurement
2
2
Device Difficult to Setup or Prepare
2
2
No Audible Alarm
2
2
Clumping in Device or Device Ingredient
2
2
Collapse
2
2
Fire
2
2
Material Puncture/Hole
2
2
Self-Activation or Keying
2
2
Expiration Date Error
2
2
Crack
2
2
Failure to Calibrate
2
2
Connection Problem
2
2
Positioning Problem
2
2
Misassembly by Users
2
2
Free or Unrestricted Flow
2
2
Device Sensing Problem
2
2
Material Twisted/Bent
2
2
Migration
2
2
Device Fell
2
2
Unexpected Shutdown
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
1
1
Program or Algorithm Execution Failure
1
1
Incomplete or Inadequate Connection
1
1
Incomplete or Inadequate Priming
1
1
Component Misassembled
1
1
Mechanical Jam
1
1
Material Deformation
1
1
Human-Device Interface Problem
1
1
Improper Chemical Reaction
1
1
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Failure to Shut Off
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1268
1268
No Patient Involvement
567
568
No Known Impact Or Consequence To Patient
112
112
Reaction
81
81
Insufficient Information
63
63
Death
46
46
Hypersensitivity/Allergic reaction
40
62
Low Blood Pressure/ Hypotension
37
59
Hemolysis
27
27
Patient Problem/Medical Problem
24
24
No Consequences Or Impact To Patient
24
24
Fever
22
22
Bacterial Infection
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
38
Tachycardia
14
14
Electrolyte Imbalance
13
35
Chest Pain
13
13
Pain
13
13
Cardiac Arrest
12
12
Dizziness
12
12
Nausea
12
12
Anemia
11
11
Loss of consciousness
11
11
Hemorrhage/Bleeding
11
11
Hypovolemia
10
10
Dyspnea
10
10
Air Embolism
10
10
Chills
9
9
Sepsis
8
8
Hematuria
8
8
Rash
8
8
Local Reaction
8
8
Numbness
7
7
Headache
7
7
Hypervolemia
7
7
Fatigue
6
6
Pallor
6
6
Unspecified Infection
6
28
Blood Loss
6
6
Hematoma
6
6
Diaphoresis
5
5
Syncope/Fainting
5
5
Discomfort
5
5
Needle Stick/Puncture
5
5
Injury
5
5
High Blood Pressure/ Hypertension
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Cough
4
4
Thrombocytopenia
4
4
Stroke/CVA
4
4
Confusion/ Disorientation
4
4
No Code Available
4
4
Erythema
4
4
Vomiting
4
4
No Information
4
4
Swelling/ Edema
3
3
Cardiovascular Insufficiency
3
3
Anaphylactic Shock
3
3
Low White Blood Cell Count
3
3
Pulmonary Embolism
3
3
Anxiety
3
3
Syncope
2
2
Incontinence
2
2
Test Result
2
2
Hemoconcentration
2
2
Sudden Cardiac Death
2
2
Thrombosis
2
2
Vaso-Vagal Response
2
2
Convulsion/Seizure
2
2
Thrombosis/Thrombus
2
2
Bradycardia
2
2
Movement Disorder
2
2
Hot Flashes/Flushes
2
2
Brain Injury
2
2
Diarrhea
2
2
Itching Sensation
2
2
Toxicity
2
2
Fungal Infection
2
2
Bruise/Contusion
2
2
Tinnitus
2
2
Tingling
2
2
Ptosis
2
2
Transient Ischemic Attack
2
2
Respiratory Failure
2
2
Anaphylactoid
1
1
Low Oxygen Saturation
1
1
Viral Infection
1
1
Abdominal Cramps
1
1
Increased Respiratory Rate
1
1
Myocardial Infarction
1
1
Respiratory Insufficiency
1
1
Edema
1
1
Low Cardiac Output
1
1
Fainting
1
1
Crushing Injury
1
1
Shaking/Tremors
1
1
Paralysis
1
1
Venipuncture
1
1
Embolism
1
1
Unspecified Blood or Lymphatic problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Apr-02-2021
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