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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
CARIDIANBCT, INC.
SUBSTANTIALLY EQUIVALENT
2
FENWAL, INC.
SUBSTANTIALLY EQUIVALENT
2
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI USA LLC
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT, INC
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT, INC.
SUBSTANTIALLY EQUIVALENT
3
TERUMO BCT, INC..
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
128
128
2015
306
306
2016
206
206
2017
169
169
2018
55
55
2019
72
72
2020
135
135
2021
63
107
2022
42
42
2023
131
131
2024
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
527
571
Insufficient Information
261
261
Inadequate User Interface
158
158
Device Displays Incorrect Message
133
133
Data Problem
126
126
Improper or Incorrect Procedure or Method
110
110
Patient Data Problem
103
103
Use of Device Problem
92
92
Excess Flow or Over-Infusion
50
50
Fluid/Blood Leak
48
48
Nonstandard Device
48
48
Patient-Device Incompatibility
47
47
Device Operates Differently Than Expected
40
40
Incorrect Software Programming Calculations
38
38
No Apparent Adverse Event
33
33
Air Leak
26
26
Leak/Splash
18
18
Device Operational Issue
17
17
Programming Issue
16
16
Occlusion Within Device
15
15
Insufficient Flow or Under Infusion
13
13
Device Alarm System
13
13
Gas/Air Leak
12
12
Obstruction of Flow
12
12
Infusion or Flow Problem
11
11
Improper Flow or Infusion
11
11
Appropriate Term/Code Not Available
10
10
Break
10
10
Misassembled
10
10
Coagulation in Device or Device Ingredient
8
8
High Test Results
8
8
Contamination of Device Ingredient or Reagent
7
7
Device Misassembled During Manufacturing /Shipping
7
7
Output Problem
6
6
Therapeutic or Diagnostic Output Failure
6
6
Defective Device
6
6
Defective Component
6
6
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Component Falling
5
5
Use of Incorrect Control/Treatment Settings
5
5
Material Discolored
5
5
Disconnection
5
5
Human-Device Interface Problem
5
5
Noise, Audible
5
5
Device Handling Problem
4
4
Pressure Problem
4
4
Incorrect Or Inadequate Test Results
4
4
Device Disinfection Or Sterilization Issue
4
4
Display or Visual Feedback Problem
4
4
Clumping in Device or Device Ingredient
4
4
Detachment Of Device Component
4
4
Microbial Contamination of Device
4
4
Unexpected Therapeutic Results
3
3
Device Slipped
3
3
Contamination
3
3
Complete Blockage
3
3
False Reading From Device Non-Compliance
3
3
Contamination /Decontamination Problem
3
3
Expiration Date Error
3
3
Device Contamination with Chemical or Other Material
3
3
Torn Material
3
3
Pumping Problem
2
2
No Flow
2
2
Material Deformation
2
2
Material Twisted/Bent
2
2
Air/Gas in Device
2
2
Component Misassembled
2
2
Misassembly by Users
2
2
Difficult to Open or Close
2
2
Inaccurate Delivery
2
2
Detachment of Device or Device Component
2
2
Inaccurate Flow Rate
2
2
Loose or Intermittent Connection
2
2
False Positive Result
2
2
Mechanical Problem
2
2
Kinked
2
2
Backflow
2
2
Partial Blockage
2
2
Positioning Failure
2
2
Crack
2
2
Shelf Life Exceeded
2
2
Device Inoperable
2
2
Volume Accuracy Problem
2
2
Component Missing
2
2
Off-Label Use
2
2
Material Puncture/Hole
1
1
Reflux within Device
1
1
Material Rupture
1
1
Self-Activation or Keying
1
1
Failure to Sense
1
1
Material Separation
1
1
Device Emits Odor
1
1
Material Opacification
1
1
Particulates
1
1
Device Difficult to Setup or Prepare
1
1
Increase in Pressure
1
1
Failure to Prime
1
1
Device Contamination with Body Fluid
1
1
Failure to Deliver
1
1
Material Perforation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
566
566
Reaction
104
104
No Clinical Signs, Symptoms or Conditions
93
93
No Information
86
86
Low Blood Pressure/ Hypotension
63
85
Death
61
61
No Code Available
52
52
Hypervolemia
51
51
No Consequences Or Impact To Patient
51
51
Hemolysis
45
45
Insufficient Information
40
40
No Patient Involvement
30
30
Blood Loss
29
29
Hypersensitivity/Allergic reaction
28
50
Itching Sensation
27
27
Dyspnea
22
22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
21
43
Test Result
20
20
Nausea
20
20
Rash
18
18
Anemia
17
17
Tachycardia
16
16
Hemorrhage/Bleeding
16
16
Chest Pain
15
15
Vomiting
15
24
Cardiac Arrest
13
13
Air Embolism
12
12
Fever
12
12
Local Reaction
12
12
Electrolyte Imbalance
12
34
Urticaria
11
11
Loss of consciousness
8
8
Paresthesia
8
17
Thrombocytopenia
8
8
Sepsis
8
21
High Blood Pressure/ Hypertension
7
7
Unspecified Infection
7
29
Bradycardia
7
7
Bacterial Infection
7
7
Chest Tightness/Pressure
7
7
Hypovolemia
7
7
Dizziness
7
7
Hematoma
6
6
Pain
6
6
Erythema
5
5
Low Oxygen Saturation
5
5
Numbness
5
5
Complaint, Ill-Defined
5
5
Syncope/Fainting
5
5
Heart Failure/Congestive Heart Failure
5
5
Liver Failure
5
5
Cramp(s) /Muscle Spasm(s)
4
4
Anxiety
4
4
Discomfort
4
4
Swelling
4
4
Diarrhea
4
13
Pulmonary Embolism
4
4
Overdose
4
4
Seizures
4
4
Hypoxia
3
3
Respiratory Distress
3
3
Abdominal Pain
3
3
Viral Infection
3
3
Sweating
3
3
Cough
3
3
Swelling/ Edema
3
3
Sore Throat
3
3
Unspecified Respiratory Problem
2
2
Unspecified Heart Problem
2
2
Diaphoresis
2
2
Malaise
2
2
Pallor
2
2
Increased Respiratory Rate
2
2
Venipuncture
2
2
Chills
2
2
Cramp(s)
2
2
Angina
2
2
Arrhythmia
2
2
Bruise/Contusion
2
2
Disseminated Intravascular Coagulation (DIC)
2
2
Cardiopulmonary Arrest
2
2
Stroke/CVA
2
2
Headache
2
2
Edema
2
2
Paralysis
2
2
Thrombosis
2
2
Hypovolemic Shock
2
2
Inflammation
2
2
Muscle Spasm(s)
2
2
Muscular Rigidity
1
1
Ischemia
1
1
Hypothermia
1
1
Hyperthermia
1
1
Hyperventilation
1
1
Intracranial Hemorrhage
1
1
Hyperbilirubinemia
1
1
Thrombus
1
1
Therapeutic Effects, Unexpected
1
1
Shock
1
1
Skin Discoloration
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Caridian BCT, Incorporated
II
Nov-16-2011
2
Caridian BCT, Incorporated
II
Jun-28-2011
3
CaridianBCT, Inc.
II
May-30-2012
4
CaridianBCT, Inc.
II
May-09-2012
5
Fenwal Inc
II
Mar-15-2023
6
Fenwal Inc
II
Apr-02-2021
7
Fenwal Inc
II
Jun-08-2013
8
Fresenius Kabi, LLC
II
May-16-2011
9
Fresenius Kabi, LLC
I
Dec-16-2010
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