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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
1. K180615
AMICUS Separator System, AMICUS Exchange Kit - The
...
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
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
517
561
Insufficient Information
244
244
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
91
91
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
30
30
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
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
Device Handling Problem
3
3
Air/Gas in Device
2
2
Component Misassembled
2
2
Misassembly by Users
2
2
Pumping Problem
2
2
No Flow
2
2
Material Deformation
2
2
Material Twisted/Bent
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
88
88
No Information
86
86
Death
61
61
Low Blood Pressure/ Hypotension
59
81
No Code Available
52
52
No Consequences Or Impact To Patient
51
51
Hypervolemia
50
50
Hemolysis
45
45
Insufficient Information
39
39
No Patient Involvement
30
30
Blood Loss
29
29
Hypersensitivity/Allergic reaction
28
50
Itching Sensation
26
26
Dyspnea
22
22
Test Result
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
41
Nausea
19
19
Rash
18
18
Tachycardia
16
16
Hemorrhage/Bleeding
15
15
Chest Pain
14
14
Vomiting
14
23
Anemia
13
13
Cardiac Arrest
13
13
Air Embolism
12
12
Electrolyte Imbalance
12
34
Local Reaction
11
11
Fever
11
11
Sepsis
8
21
Urticaria
8
8
Loss of consciousness
8
8
Paresthesia
8
17
Chest Tightness/Pressure
7
7
Dizziness
7
7
High Blood Pressure/ Hypertension
7
7
Unspecified Infection
7
29
Bradycardia
7
7
Bacterial Infection
7
7
Hypovolemia
6
6
Thrombocytopenia
6
6
Syncope/Fainting
5
5
Heart Failure/Congestive Heart Failure
5
5
Liver Failure
5
5
Complaint, Ill-Defined
5
5
Low Oxygen Saturation
5
5
Erythema
5
5
Hematoma
5
5
Pain
5
5
Seizures
4
4
Swelling
4
4
Overdose
4
4
Diarrhea
4
13
Pulmonary Embolism
4
4
Numbness
4
4
Anxiety
4
4
Discomfort
4
4
Cramp(s) /Muscle Spasm(s)
4
4
Cough
3
3
Swelling/ Edema
3
3
Viral Infection
3
3
Sweating
3
3
Sore Throat
3
3
Hypoxia
3
3
Respiratory Distress
3
3
Paralysis
2
2
Venipuncture
2
2
Thrombosis
2
2
Muscle Spasm(s)
2
2
Hypovolemic Shock
2
2
Inflammation
2
2
Headache
2
2
Abdominal Pain
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
Edema
2
2
Increased Respiratory Rate
2
2
Diaphoresis
2
2
Pallor
2
2
Malaise
2
2
Chills
2
2
Cramp(s)
2
2
Unspecified Respiratory Problem
2
2
Unspecified Heart Problem
2
2
Movement Disorder
1
1
Low White Blood Cell Count
1
1
Thrombosis/Thrombus
1
1
Alteration In Body Temperature
1
1
Patient Problem/Medical Problem
1
1
Convulsion/Seizure
1
1
Presyncope
1
1
Wheezing
1
1
Muscle Hypotonia
1
1
Nodule
1
1
Alteration in Body Temperature
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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