Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
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
7
FRESENIUS KABI USA LLC.
SUBSTANTIALLY EQUIVALENT
1
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
TERUMO BCT, INC
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2018
354
354
2019
434
434
2020
561
561
2021
490
512
2022
462
462
2023
158
158
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1561
1583
High Test Results
340
340
Insufficient Information
250
250
High Readings
234
234
No Apparent Adverse Event
131
131
Use of Device Problem
122
122
Mechanical Problem
117
117
Contamination of Device Ingredient or Reagent
106
106
Device Slipped
92
92
Thermal Decomposition of Device
86
86
Temperature Problem
68
68
Incorrect, Inadequate or Imprecise Result or Readings
65
65
Appropriate Term/Code Not Available
49
49
Device Displays Incorrect Message
41
41
Improper or Incorrect Procedure or Method
40
40
Gas/Air Leak
37
37
Unintended Movement
36
36
Excess Flow or Over-Infusion
36
36
Fluid/Blood Leak
35
35
Output Problem
31
31
Patient-Device Incompatibility
30
30
Microbial Contamination of Device
29
29
Overheating of Device
28
28
Air/Gas in Device
22
22
Therapeutic or Diagnostic Output Failure
20
20
Inadequate User Interface
20
20
Device Operates Differently Than Expected
17
17
Coagulation in Device or Device Ingredient
17
17
Defective Component
16
16
Obstruction of Flow
15
15
Leak/Splash
15
15
Misassembled
14
14
Infusion or Flow Problem
14
14
Device Ingredient or Reagent Problem
14
14
Device Handling Problem
11
11
Smoking
11
11
Pressure Problem
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Defective Device
9
9
Human-Device Interface Problem
9
9
Loose or Intermittent Connection
9
9
Computer Software Problem
9
9
Device Misassembled During Manufacturing /Shipping
8
8
Overfill
8
8
Contamination /Decontamination Problem
7
7
Data Problem
7
7
Complete Blockage
7
7
Increase in Pressure
7
7
Clumping in Device or Device Ingredient
6
6
Component Falling
6
6
Contamination
6
6
Display or Visual Feedback Problem
5
5
Device Alarm System
5
5
Backflow
5
5
Patient Device Interaction Problem
5
5
Improper Flow or Infusion
5
5
Material Integrity Problem
5
5
Device Contamination with Chemical or Other Material
4
4
Detachment of Device or Device Component
4
4
Noise, Audible
4
4
Air Leak
4
4
Disconnection
4
4
False Positive Result
4
4
Unexpected Therapeutic Results
4
4
Decrease in Pressure
3
3
Component Missing
3
3
Self-Activation or Keying
3
3
Occlusion Within Device
3
3
Unintended System Motion
3
3
Fire
3
3
Partial Blockage
3
3
Break
3
3
Patient Data Problem
3
3
Protective Measures Problem
3
3
Mechanics Altered
3
3
No Flow
3
3
Connection Problem
3
3
Low Test Results
3
3
Material Twisted/Bent
3
3
Free or Unrestricted Flow
2
2
Device Sensing Problem
2
2
Expiration Date Error
2
2
Sparking
2
2
No Pressure
2
2
Positioning Problem
2
2
Misassembly by Users
2
2
Migration
2
2
Material Split, Cut or Torn
2
2
Device Fell
2
2
Unexpected Shutdown
2
2
Incomplete or Inadequate Connection
2
2
No Audible Alarm
2
2
Collapse
2
2
Hole In Material
2
2
No Display/Image
2
2
Crack
2
2
Incorrect Measurement
2
2
Material Puncture/Hole
2
2
Loss of Power
2
2
Device Difficult to Setup or Prepare
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1072
1072
No Patient Involvement
795
796
No Known Impact Or Consequence To Patient
194
194
Reaction
98
98
Insufficient Information
63
63
Death
58
58
Hypersensitivity/Allergic reaction
39
61
Low Blood Pressure/ Hypotension
39
61
No Consequences Or Impact To Patient
35
35
Hemolysis
28
28
Patient Problem/Medical Problem
26
26
Bacterial Infection
24
24
Fever
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
37
Anemia
14
14
Electrolyte Imbalance
14
36
Nausea
13
13
Tachycardia
13
13
Chest Pain
13
13
Pain
12
12
Dizziness
11
11
Cardiac Arrest
11
11
Dyspnea
10
10
Chills
10
10
Loss of consciousness
10
10
No Information
8
8
Hypervolemia
8
8
Vomiting
8
8
Rash
8
8
Headache
8
8
Hematoma
8
8
Hemorrhage/Bleeding
8
8
Local Reaction
7
7
Unspecified Infection
6
28
Sepsis
6
6
Tingling
6
6
Discomfort
6
6
High Blood Pressure/ Hypertension
6
6
Erythema
6
6
Fatigue
6
6
Blood Loss
6
6
Numbness
6
6
Injury
5
5
Needle Stick/Puncture
5
5
No Code Available
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Cough
4
4
Thrombocytopenia
4
4
Pallor
4
4
Toxicity
4
4
Diaphoresis
4
4
Stroke/CVA
4
4
Itching Sensation
4
4
Thrombosis
3
3
Anxiety
3
3
Hypovolemia
3
3
Diarrhea
3
3
Pulmonary Embolism
3
3
Air Embolism
3
3
Anaphylactic Shock
3
3
Low White Blood Cell Count
3
3
Test Result
3
3
Confusion/ Disorientation
3
3
Vaso-Vagal Response
3
3
Swelling/ Edema
3
3
Syncope/Fainting
3
3
Movement Disorder
2
2
Cardiovascular Insufficiency
2
2
Hematuria
2
2
Ptosis
2
2
Fungal Infection
2
2
Sudden Cardiac Death
2
2
Syncope
2
2
Exposure to Body Fluids
2
2
Bradycardia
2
2
Bruise/Contusion
2
2
Hemoconcentration
2
2
Viral Infection
2
2
Cramp(s)
2
2
Infiltration into Tissue
2
2
Muscle Weakness
1
1
Myocardial Infarction
1
1
Staphylococcus Aureus
1
1
Seizures
1
1
Transient Ischemic Attack
1
1
Venipuncture
1
1
Septic Shock
1
1
Skin Discoloration
1
1
Paralysis
1
1
Hot Flashes/Flushes
1
1
Immunodeficiency
1
1
Anaphylactoid
1
1
Brain Injury
1
1
Stenosis
1
1
Therapeutic Response, Decreased
1
1
Complaint, Ill-Defined
1
1
Cardiopulmonary Arrest
1
1
Crushing Injury
1
1
Cyanosis
1
1
Abdominal Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Apr-02-2021
-
-