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TPLC
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show TPLC since
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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
MDR Year
MDR Reports
MDR Events
2019
72
72
2020
135
135
2021
63
107
2022
42
42
2023
132
132
2024
145
145
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
417
461
Insufficient Information
282
282
No Apparent Adverse Event
56
56
Use of Device Problem
34
34
Patient-Device Incompatibility
27
27
Improper or Incorrect Procedure or Method
16
16
Fluid/Blood Leak
16
16
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
Appropriate Term/Code Not Available
6
6
Therapeutic or Diagnostic Output Failure
6
6
Output Problem
6
6
Leak/Splash
6
6
Defective Device
5
5
Device Alarm System
5
5
Inadequate User Interface
5
5
Improper Flow or Infusion
5
5
Excess Flow or Over-Infusion
5
5
Break
5
5
Misassembled
5
5
Device Handling Problem
5
5
Defective Component
4
4
Material Discolored
4
4
Mechanical Problem
4
4
Device Slipped
4
4
Coagulation in Device or Device Ingredient
3
3
Pumping Problem
2
2
Expiration Date Error
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Microbial Contamination of Device
2
2
Contamination /Decontamination Problem
2
2
Display or Visual Feedback Problem
2
2
Air/Gas in Device
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Backflow
2
2
Off-Label Use
2
2
Inaccurate Flow Rate
2
2
Contamination of Device Ingredient or Reagent
2
2
Human-Device Interface Problem
2
2
Component Misassembled
2
2
No Flow
1
1
Improper Chemical Reaction
1
1
Loss of or Failure to Bond
1
1
Difficult to Open or Close
1
1
Noise, Audible
1
1
Self-Activation or Keying
1
1
Priming Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
127
127
Low Blood Pressure/ Hypotension
61
83
No Known Impact Or Consequence To Patient
57
57
Reaction
44
44
Hemolysis
42
42
Insufficient Information
42
42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
35
57
Death
34
34
Hypersensitivity/Allergic reaction
33
55
Itching Sensation
20
20
Rash
19
19
Tachycardia
17
17
Dyspnea
16
16
Hypervolemia
16
16
Local Reaction
15
15
Vomiting
14
23
Nausea
14
14
Fever
13
13
Air Embolism
13
13
Anemia
12
12
Chest Pain
12
12
Urticaria
11
11
Paresthesia
11
20
Syncope/Fainting
10
10
Dizziness
9
9
Electrolyte Imbalance
9
31
No Consequences Or Impact To Patient
9
9
Sepsis
9
22
Hemorrhage/Bleeding
9
9
High Blood Pressure/ Hypertension
8
8
Cardiac Arrest
8
8
Thrombocytopenia
8
8
Blood Loss
8
8
Bacterial Infection
7
7
Hematoma
7
7
Unspecified Infection
7
29
Pulmonary Embolism
5
5
Diarrhea
5
14
Pain
5
5
Numbness
5
5
Hypovolemia
5
5
No Patient Involvement
5
5
Heart Failure/Congestive Heart Failure
5
5
Liver Failure
5
5
Swelling/ Edema
5
5
Cramp(s) /Muscle Spasm(s)
4
4
No Information
4
4
Chills
4
4
Erythema
4
4
Arrhythmia
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Mar-15-2023
2
Fenwal Inc
II
Apr-02-2021
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