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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
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2018
2019
2020
2021
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2024
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Device
system, photopheresis, extracorporeal
Product Code
LNR
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
1
7
5
7
2
5
5
8
4
2
1
2
3
3
0
MDR Year
MDR Reports
MDR Events
2014
377
377
2015
319
319
2016
318
318
2017
261
261
2018
183
183
2019
161
161
2020
141
141
2021
114
114
2022
97
97
2023
83
83
2024
97
97
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
908
908
Leak/Splash
659
659
Device Displays Incorrect Message
564
564
Break
408
408
Adverse Event Without Identified Device or Use Problem
155
155
Device Alarm System
90
90
Noise, Audible
82
82
Device Contamination with Body Fluid
55
55
Air Leak
55
55
Device Operates Differently Than Expected
52
52
Crack
41
41
Detachment Of Device Component
41
41
Occlusion Within Device
28
28
Hole In Material
26
26
Insufficient Information
23
23
Coagulation in Device or Device Ingredient
21
21
Improper or Incorrect Procedure or Method
21
21
Device Dislodged or Dislocated
18
18
Detachment of Device or Device Component
18
18
Disconnection
17
17
Pressure Problem
17
17
Protective Measures Problem
16
16
Use of Device Problem
15
15
Material Puncture/Hole
12
12
Torn Material
11
11
Gas/Air Leak
11
11
Loose or Intermittent Connection
11
11
Unintended Ejection
10
10
Material Fragmentation
10
10
Defective Alarm
9
9
Obstruction of Flow
9
9
Output Problem
9
9
Visual Prompts will not Clear
8
8
Burst Container or Vessel
8
8
Display or Visual Feedback Problem
8
8
Bent
7
7
Material Separation
7
7
Failure to Prime
7
7
Infusion or Flow Problem
7
7
Split
6
6
Device Emits Odor
6
6
Loss of Power
6
6
Positioning Problem
5
5
Component Falling
5
5
Fitting Problem
4
4
Increase in Pressure
4
4
Sticking
4
4
Air/Gas in Device
4
4
Malposition of Device
4
4
Moisture or Humidity Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
866
866
No Clinical Signs, Symptoms or Conditions
382
382
Blood Loss
211
211
No Consequences Or Impact To Patient
204
204
Hemorrhage/Bleeding
120
120
No Information
53
53
No Code Available
53
53
Low Blood Pressure/ Hypotension
52
52
Dyspnea
39
39
Pulmonary Embolism
33
33
Thrombosis
27
27
Death
20
21
Nausea
20
20
Anemia
19
19
Malaise
17
17
Tachycardia
17
17
Low Oxygen Saturation
15
15
Unspecified Infection
14
14
Chest Pain
14
14
Thrombus
14
14
No Patient Involvement
12
12
Dizziness
12
12
Patient Problem/Medical Problem
11
11
Insufficient Information
11
11
Fever
10
10
High Blood Pressure/ Hypertension
10
10
Swelling
10
10
Hypoxia
9
9
Vomiting
9
9
Fainting
9
9
Pain
9
9
Fatigue
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Headache
7
7
Pallor
7
7
Test Result
7
7
Tingling
7
7
Numbness
6
6
Complaint, Ill-Defined
6
6
Paresthesia
5
5
Chills
5
5
Weakness
5
5
Abdominal Pain
5
5
Itching Sensation
5
5
Multiple Organ Failure
5
5
Respiratory Failure
5
5
Hyperglycemia
5
5
Reaction
5
5
Respiratory Distress
5
5
Diarrhea
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Mallinckrodt Pharmaceuticals Ireland Ltd
II
Feb-07-2022
2
Therakos Inc
II
Apr-05-2016
3
Therakos Inc
II
Jul-19-2011
4
Therakos Inc
II
Apr-28-2011
5
Therakos Inc
II
May-26-2010
6
Therakos, Inc.
II
Nov-05-2021
7
Therakos, Inc.
II
Jan-11-2012
8
Therakos, Inc.
II
Aug-10-2011
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