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TPLC
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show TPLC since
2009
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2011
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2014
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2020
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2024
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Device
infusor, pressure, for i.v. bags
Product Code
KZD
Regulation Number
880.5420
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
72
72
2015
31
31
2016
4
4
2017
38
38
2018
6
6
2019
4
4
2020
8
8
2021
13
13
2022
45
45
2023
31
31
2024
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Air Leak
109
109
Loss of or Failure to Bond
93
93
Leak/Splash
44
44
Gas/Air Leak
23
23
Pressure Problem
20
20
Decrease in Pressure
15
15
Device Contamination with Chemical or Other Material
12
12
Crack
9
9
Unintended Deflation
6
6
Inflation Problem
6
6
Break
5
5
Disconnection
5
5
Appropriate Term/Code Not Available
5
5
Material Integrity Problem
4
4
Detachment of Device or Device Component
4
4
Mechanical Problem
4
4
Missing Value Reason
4
4
Fluid/Blood Leak
4
4
Device Operates Differently Than Expected
4
4
Device Markings/Labelling Problem
3
3
Insufficient Information
3
3
Defective Device
3
3
Burst Container or Vessel
3
3
Device Handling Problem
2
2
Infusion or Flow Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Deflation Problem
2
2
Material Split, Cut or Torn
2
2
Inaccurate Delivery
2
2
Fracture
2
2
Detachment Of Device Component
2
2
Backflow
2
2
Inadequate User Interface
1
1
Component Falling
1
1
Failure to Deflate
1
1
Device Operational Issue
1
1
Free or Unrestricted Flow
1
1
Explosion
1
1
No Display/Image
1
1
Incomplete or Inadequate Connection
1
1
Air/Gas in Device
1
1
Component Missing
1
1
Contamination
1
1
Use of Device Problem
1
1
Improper Flow or Infusion
1
1
Material Fragmentation
1
1
Obstruction of Flow
1
1
Insufficient Flow or Under Infusion
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Failure to Zero
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
109
109
No Clinical Signs, Symptoms or Conditions
86
86
Insufficient Information
26
26
No Consequences Or Impact To Patient
25
25
No Code Available
6
6
No Information
6
6
Missing Value Reason
6
6
Air Embolism
5
5
No Patient Involvement
3
3
Low Blood Pressure/ Hypotension
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Death
2
2
Cardiac Arrest
2
2
Urinary Tract Infection
2
2
Hearing Impairment
1
1
Arrhythmia
1
1
Not Applicable
1
1
Respiratory Arrest
1
1
Misdiagnosis
1
1
Embolism/Embolus
1
1
Atrial Fibrillation
1
1
Foreign Body In Patient
1
1
Sudden Cardiac Death
1
1
Respiratory Insufficiency
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Jun-26-2017
2
GE Healthcare, LLC
II
Jun-24-2011
3
Merit Medical Systems, Inc.
II
Dec-14-2009
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