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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
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
497
541
Insufficient Information
222
222
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
89
89
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
Air Leak
26
26
No Apparent Adverse Event
25
25
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
Improper Flow or Infusion
11
11
Infusion or Flow Problem
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
Defective Device
6
6
Device Misassembled During Manufacturing /Shipping
6
6
Output Problem
6
6
Therapeutic or Diagnostic Output Failure
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
Noise, Audible
5
5
Human-Device Interface Problem
5
5
Device Disinfection Or Sterilization Issue
4
4
Incorrect Or Inadequate Test Results
4
4
Pressure Problem
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
Contamination
3
3
Complete Blockage
3
3
False Reading From Device Non-Compliance
3
3
Torn Material
3
3
Device Handling Problem
3
3
Contamination /Decontamination Problem
3
3
Expiration Date Error
3
3
Device Contamination with Chemical or Other Material
3
3
Difficult to Open or Close
2
2
Detachment of Device or Device Component
2
2
Off-Label Use
2
2
Inaccurate Delivery
2
2
Air/Gas in Device
2
2
Component Misassembled
2
2
No Flow
2
2
Misassembly by Users
2
2
Pumping Problem
2
2
Material Deformation
2
2
Material Twisted/Bent
2
2
Inaccurate Flow Rate
2
2
Loose or Intermittent Connection
2
2
Kinked
2
2
Backflow
2
2
Partial Blockage
2
2
Positioning Failure
2
2
Crack
2
2
Device Inoperable
2
2
Volume Accuracy Problem
2
2
Shelf Life Exceeded
2
2
Device Slipped
2
2
Component Missing
2
2
False Positive Result
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
Visual Prompts will not Clear
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 Information
86
86
No Clinical Signs, Symptoms or Conditions
76
76
Death
61
61
Low Blood Pressure/ Hypotension
57
79
No Code Available
52
52
No Consequences Or Impact To Patient
51
51
Hypervolemia
47
47
Hemolysis
41
41
Insufficient Information
36
36
No Patient Involvement
30
30
Blood Loss
29
29
Hypersensitivity/Allergic reaction
27
49
Itching Sensation
26
26
Dyspnea
22
22
Test Result
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
41
Rash
18
18
Nausea
17
17
Tachycardia
15
15
Hemorrhage/Bleeding
15
15
Chest Pain
13
13
Cardiac Arrest
13
13
Vomiting
12
21
Air Embolism
12
12
Electrolyte Imbalance
12
34
Anemia
11
11
Fever
11
11
Local Reaction
11
11
Loss of consciousness
8
8
Sepsis
8
21
Paresthesia
8
17
Urticaria
8
8
Chest Tightness/Pressure
7
7
Bradycardia
7
7
Bacterial Infection
7
7
High Blood Pressure/ Hypertension
7
7
Unspecified Infection
7
29
Dizziness
7
7
Hypovolemia
6
6
Low Oxygen Saturation
5
5
Liver Failure
5
5
Syncope/Fainting
5
5
Pain
5
5
Erythema
5
5
Thrombocytopenia
5
5
Complaint, Ill-Defined
5
5
Heart Failure/Congestive Heart Failure
5
5
Cramp(s) /Muscle Spasm(s)
4
4
Anxiety
4
4
Seizures
4
4
Pulmonary Embolism
4
4
Swelling
4
4
Numbness
4
4
Diarrhea
4
13
Discomfort
4
4
Overdose
4
4
Hematoma
4
4
Viral Infection
3
3
Swelling/ Edema
3
3
Hypoxia
3
3
Sweating
3
3
Sore Throat
3
3
Respiratory Distress
3
3
Cough
3
3
Unspecified Respiratory Problem
2
2
Hypovolemic Shock
2
2
Disseminated Intravascular Coagulation (DIC)
2
2
Angina
2
2
Thrombosis
2
2
Muscle Spasm(s)
2
2
Inflammation
2
2
Malaise
2
2
Pallor
2
2
Cramp(s)
2
2
Chills
2
2
Abdominal Pain
2
2
Arrhythmia
2
2
Stroke/CVA
2
2
Cardiopulmonary Arrest
2
2
Venipuncture
2
2
Paralysis
2
2
Headache
2
2
Increased Respiratory Rate
2
2
Bruise/Contusion
2
2
Edema
2
2
Unspecified Heart Problem
2
2
Diaphoresis
2
2
Respiratory Failure
1
1
Hyperthermia
1
1
Fall
1
1
Collapse
1
1
Renal Failure
1
1
Dehydration
1
1
Apnea
1
1
Pulmonary Edema
1
1
Hyperbilirubinemia
1
1
Tingling
1
1
Patient Problem/Medical Problem
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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