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TPLC
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Device
illuminator system for blood products
Definition
Preparation and storage of pathogen-reduced, blood components.
Product Code
PJF
Device Class
3
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
7
7
2017
2
2
2018
4
4
2020
1
1
2021
5
5
2022
2
2
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
11
11
Appropriate Term/Code Not Available
5
5
Insufficient Information
3
3
Contamination
2
2
Fluid/Blood Leak
2
2
Improper or Incorrect Procedure or Method
2
2
Microbial Contamination of Device
1
1
False Negative Result
1
1
Calibration Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
9
9
Sepsis
6
6
Insufficient Information
3
3
Bacterial Infection
3
3
Fever
2
2
Chills
2
2
Alteration in Body Temperature
2
2
Reaction
2
2
Tachycardia
2
2
High Blood Pressure/ Hypertension
1
1
Liver Failure
1
1
Infection, Indirect
1
1
No Information
1
1
Malaise
1
1
Anaphylactoid
1
1
Alteration In Body Temperature
1
1
No Known Impact Or Consequence To Patient
1
1
Cardiac Arrest
1
1
Septic Shock
1
1
Shock
1
1
Renal Failure
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Failure
1
1
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