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TPLC
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show TPLC since
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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
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
132
132
2024
123
123
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
564
608
Insufficient Information
319
319
Inadequate User Interface
162
162
Device Displays Incorrect Message
133
133
Data Problem
126
126
Improper or Incorrect Procedure or Method
112
112
Patient Data Problem
103
103
Use of Device Problem
92
92
Excess Flow or Over-Infusion
50
50
No Apparent Adverse Event
48
48
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
Leak/Splash
18
18
Device Operational Issue
17
17
Programming Issue
16
16
Occlusion Within Device
15
15
Device Alarm System
13
13
Insufficient Flow or Under Infusion
13
13
Gas/Air Leak
12
12
Obstruction of Flow
12
12
Improper Flow or Infusion
11
11
Infusion or Flow Problem
11
11
Break
10
10
Misassembled
10
10
Appropriate Term/Code Not Available
10
10
Coagulation in Device or Device Ingredient
8
8
High Test Results
8
8
Human-Device Interface Problem
7
7
Device Misassembled During Manufacturing /Shipping
7
7
Contamination of Device Ingredient or Reagent
7
7
Output Problem
6
6
Defective Component
6
6
Defective Device
6
6
Therapeutic or Diagnostic Output Failure
6
6
Disconnection
5
5
Component Falling
5
5
Use of Incorrect Control/Treatment Settings
5
5
Noise, Audible
5
5
Material Discolored
5
5
Device Handling Problem
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Incorrect Or Inadequate Test Results
4
4
Display or Visual Feedback Problem
4
4
Device Slipped
4
4
Pressure Problem
4
4
Detachment Of Device Component
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
566
566
No Clinical Signs, Symptoms or Conditions
118
118
Reaction
104
104
No Information
86
86
Low Blood Pressure/ Hypotension
80
102
Death
61
61
Hypervolemia
53
53
No Code Available
52
52
No Consequences Or Impact To Patient
51
51
Hemolysis
48
48
Insufficient Information
41
41
Hypersensitivity/Allergic reaction
34
56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
32
54
No Patient Involvement
30
30
Blood Loss
29
29
Itching Sensation
28
28
Dyspnea
24
24
Rash
20
20
Nausea
20
20
Test Result
20
20
Tachycardia
19
19
Vomiting
17
26
Hemorrhage/Bleeding
17
17
Anemia
17
17
Fever
15
15
Chest Pain
15
15
Local Reaction
14
14
Urticaria
13
13
Cardiac Arrest
13
13
Electrolyte Imbalance
12
34
Air Embolism
12
12
Paresthesia
10
19
Syncope/Fainting
9
9
Sepsis
9
22
Dizziness
9
9
Bradycardia
8
8
Thrombocytopenia
8
8
Loss of consciousness
8
8
Bacterial Infection
8
8
High Blood Pressure/ Hypertension
8
8
Hematoma
7
7
Chest Tightness/Pressure
7
7
Hypovolemia
7
7
Unspecified Infection
7
29
Pain
6
6
Heart Failure/Congestive Heart Failure
5
5
Swelling/ Edema
5
5
Numbness
5
5
Complaint, Ill-Defined
5
5
Liver Failure
5
5
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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