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TPLC
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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
6
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
489
511
2022
462
462
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1393
1415
High Test Results
332
332
High Readings
233
233
Insufficient Information
142
142
Use of Device Problem
116
116
Mechanical Problem
108
108
No Apparent Adverse Event
104
104
Contamination of Device Ingredient or Reagent
101
101
Device Slipped
86
86
Thermal Decomposition of Device
86
86
Temperature Problem
68
68
Incorrect, Inadequate or Imprecise Result or Readings
64
64
Appropriate Term/Code Not Available
49
49
Device Displays Incorrect Message
40
40
Improper or Incorrect Procedure or Method
40
40
Gas/Air Leak
37
37
Unintended Movement
36
36
Excess Flow or Over-Infusion
35
35
Fluid/Blood Leak
30
30
Output Problem
30
30
Patient-Device Incompatibility
30
30
Overheating of Device
28
28
Microbial Contamination 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
Defective Component
16
16
Coagulation in Device or Device Ingredient
16
16
Obstruction of Flow
15
15
Device Ingredient or Reagent Problem
14
14
Infusion or Flow Problem
13
13
Leak/Splash
13
13
Misassembled
13
13
Smoking
11
11
Pressure Problem
10
10
Device Handling Problem
9
9
Manufacturing, Packaging or Shipping Problem
9
9
Defective Device
9
9
Human-Device Interface Problem
9
9
Loose or Intermittent Connection
9
9
Computer Software Problem
9
9
Overfill
8
8
Device Misassembled During Manufacturing /Shipping
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
Contamination /Decontamination Problem
6
6
Improper Flow or Infusion
5
5
Material Integrity Problem
5
5
Patient Device Interaction Problem
5
5
Display or Visual Feedback Problem
5
5
Device Alarm System
5
5
Backflow
5
5
Air Leak
4
4
Disconnection
4
4
False Positive Result
4
4
Unexpected Therapeutic Results
4
4
Noise, Audible
4
4
Device Contamination with Chemical or Other Material
4
4
Detachment of Device or Device Component
4
4
Connection Problem
3
3
Low Test Results
3
3
Material Twisted/Bent
3
3
Patient Data Problem
3
3
Protective Measures Problem
3
3
Mechanics Altered
3
3
No Flow
3
3
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
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
Loss of Power
2
2
Device Difficult to Setup or Prepare
2
2
Failure to Calibrate
2
2
Failure to Deliver
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
Free or Unrestricted Flow
2
2
Device Sensing Problem
2
2
Expiration Date Error
2
2
Sparking
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
947
947
No Patient Involvement
795
796
No Known Impact Or Consequence To Patient
194
194
Reaction
98
98
Insufficient Information
60
60
Death
58
58
Hypersensitivity/Allergic reaction
35
57
Low Blood Pressure/ Hypotension
35
57
No Consequences Or Impact To Patient
35
35
Hemolysis
26
26
Patient Problem/Medical Problem
26
26
Fever
18
18
Bacterial Infection
16
16
Anemia
14
14
Chest Pain
12
12
Electrolyte Imbalance
12
34
Pain
12
12
Tachycardia
12
12
Nausea
11
11
Cardiac Arrest
11
11
Dizziness
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
32
Loss of consciousness
9
9
Chills
9
9
Dyspnea
9
9
Headache
8
8
Hematoma
8
8
Rash
8
8
No Information
8
8
Local Reaction
7
7
Unspecified Infection
6
28
Tingling
6
6
Vomiting
6
6
Discomfort
6
6
High Blood Pressure/ Hypertension
6
6
Erythema
6
6
Fatigue
6
6
Blood Loss
6
6
Hypervolemia
5
5
No Code Available
5
5
Numbness
5
5
Injury
5
5
Needle Stick/Puncture
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Hemorrhage/Bleeding
5
5
Sepsis
5
5
Itching Sensation
4
4
Thrombocytopenia
4
4
Pallor
4
4
Toxicity
4
4
Anxiety
3
3
Syncope/Fainting
3
3
Diaphoresis
3
3
Test Result
3
3
Vaso-Vagal Response
3
3
Confusion/ Disorientation
3
3
Low White Blood Cell Count
3
3
Cough
3
3
Swelling/ Edema
3
3
Thrombosis
3
3
Hypovolemia
3
3
Stroke/CVA
3
3
Anaphylactic Shock
3
3
Pulmonary Embolism
3
3
Syncope
2
2
Hemoconcentration
2
2
Air Embolism
2
2
Exposure to Body Fluids
2
2
Bradycardia
2
2
Bruise/Contusion
2
2
Viral Infection
2
2
Cramp(s)
2
2
Infiltration into Tissue
2
2
Cardiovascular Insufficiency
2
2
Hematuria
2
2
Ptosis
2
2
Movement Disorder
2
2
Sudden Cardiac Death
2
2
Shaking/Tremors
1
1
Abdominal Cramps
1
1
Nasal Obstruction
1
1
Low Oxygen Saturation
1
1
Respiratory Failure
1
1
Low Cardiac Output
1
1
Malaise
1
1
Coma
1
1
Fungal Infection
1
1
Sweating
1
1
Convulsion/Seizure
1
1
Lethargy
1
1
Alteration In Body Temperature
1
1
Reaction to Medicinal Component of Device
1
1
Unspecified Blood or Lymphatic problem
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Muscle Weakness
1
1
Myocardial Infarction
1
1
Staphylococcus Aureus
1
1
Seizures
1
1
Transient Ischemic Attack
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Apr-02-2021
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