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TPLC
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2024
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Device
separator, automated, blood cell and plasma, therapeutic
Product Code
LKN
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K183081
Spectra Optia Apheresis System
MDR Year
MDR Reports
MDR Events
2019
72
72
2020
135
135
2021
63
107
2022
42
42
2023
131
131
2024
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
343
387
Insufficient Information
172
172
Use of Device Problem
33
33
No Apparent Adverse Event
28
28
Patient-Device Incompatibility
27
27
Fluid/Blood Leak
16
16
Improper or Incorrect Procedure or Method
14
14
Gas/Air Leak
12
12
Device Displays Incorrect Message
10
10
Insufficient Flow or Under Infusion
8
8
Obstruction of Flow
8
8
Infusion or Flow Problem
7
7
Output Problem
6
6
Therapeutic or Diagnostic Output Failure
6
6
Appropriate Term/Code Not Available
6
6
Leak/Splash
6
6
Excess Flow or Over-Infusion
5
5
Misassembled
5
5
Device Alarm System
5
5
Break
5
5
Improper Flow or Infusion
5
5
Defective Device
5
5
Material Discolored
4
4
Defective Component
4
4
Coagulation in Device or Device Ingredient
3
3
Device Handling Problem
3
3
Component Misassembled
2
2
Air/Gas in Device
2
2
Expiration Date Error
2
2
Pumping Problem
2
2
Device Slipped
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Microbial Contamination of Device
2
2
Contamination /Decontamination Problem
2
2
Contamination of Device Ingredient or Reagent
2
2
Display or Visual Feedback Problem
2
2
Inaccurate Flow Rate
2
2
Backflow
2
2
Off-Label Use
2
2
Mechanical Problem
2
2
Material Puncture/Hole
1
1
Reflux within Device
1
1
Nonstandard Device
1
1
Loss of or Failure to Bond
1
1
No Audible Alarm
1
1
Alarm Not Visible
1
1
Complete Blockage
1
1
Device Markings/Labelling Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Difficult to Open or Close
1
1
Free or Unrestricted Flow
1
1
High Test Results
1
1
Structural Problem
1
1
Volume Accuracy Problem
1
1
Component Missing
1
1
Inaccurate Delivery
1
1
Self-Activation or Keying
1
1
Inadequate User Interface
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Improper Chemical Reaction
1
1
Installation-Related Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
No Flow
1
1
Priming Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
81
81
No Known Impact Or Consequence To Patient
57
57
Reaction
44
44
Insufficient Information
39
39
Low Blood Pressure/ Hypotension
36
58
Hemolysis
34
34
Death
34
34
Hypersensitivity/Allergic reaction
25
47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
41
Itching Sensation
18
18
Rash
17
17
Hypervolemia
12
12
Local Reaction
11
11
Tachycardia
11
11
Dyspnea
11
11
Air Embolism
11
11
Nausea
10
10
Fever
9
9
Chest Pain
9
9
Vomiting
9
18
Electrolyte Imbalance
9
31
No Consequences Or Impact To Patient
9
9
Blood Loss
8
8
Sepsis
8
21
Cardiac Arrest
8
8
Paresthesia
8
17
Hemorrhage/Bleeding
7
7
High Blood Pressure/ Hypertension
6
6
Unspecified Infection
6
28
Bacterial Infection
6
6
Anemia
6
6
Hematoma
5
5
Dizziness
5
5
No Patient Involvement
5
5
Thrombocytopenia
5
5
Syncope/Fainting
5
5
Heart Failure/Congestive Heart Failure
5
5
Liver Failure
5
5
Cramp(s) /Muscle Spasm(s)
4
4
No Information
4
4
Numbness
4
4
Urticaria
4
4
Pain
4
4
Pulmonary Embolism
4
4
Diarrhea
4
13
Erythema
4
4
Anxiety
3
3
Hypoxia
3
3
Hypovolemia
3
3
Chest Tightness/Pressure
3
3
Low Oxygen Saturation
3
3
Cough
3
3
Swelling/ Edema
3
3
Unspecified Respiratory Problem
2
2
Unspecified Heart Problem
2
2
Pallor
2
2
Sweating
2
2
Loss of consciousness
2
2
Discomfort
2
2
Malaise
2
2
Headache
2
2
Arrhythmia
2
2
Paralysis
2
2
Inflammation
2
2
Hypovolemic Shock
2
2
Hypothermia
1
1
Hyperthermia
1
1
Hyperbilirubinemia
1
1
Ischemia
1
1
Muscular Rigidity
1
1
Pulmonary Edema
1
1
Overdose
1
1
Atrial Fibrillation
1
1
Autoimmune Disorder
1
1
Exposure to Body Fluids
1
1
Bradycardia
1
1
Cardiomyopathy
1
1
Stroke/CVA
1
1
Hearing Impairment
1
1
Sore Throat
1
1
Hot Flashes/Flushes
1
1
Chills
1
1
Shock
1
1
Thrombosis
1
1
Respiratory Distress
1
1
Seizures
1
1
Encephalitis
1
1
Diaphoresis
1
1
Respiratory Failure
1
1
Increased Respiratory Rate
1
1
Cognitive Changes
1
1
Hematuria
1
1
Loss Of Pulse
1
1
Movement Disorder
1
1
Wheezing
1
1
Convulsion/Seizure
1
1
Presyncope
1
1
Low White Blood Cell Count
1
1
Thrombosis/Thrombus
1
1
Muscle Hypotonia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Mar-15-2023
2
Fenwal Inc
II
Apr-02-2021
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