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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device illuminator system for blood products
Definition Preparation and storage of pathogen-reduced, blood components.
Product CodePJF
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
Calibration Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 9 9
Sepsis 6 6
Bacterial Infection 3 3
Insufficient Information 3 3
Alteration in Body Temperature 2 2
Fever 2 2
Tachycardia 2 2
Chills 2 2
Reaction 2 2
Respiratory Failure 1 1
Alteration In Body Temperature 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Anaphylactoid 1 1
Infection, Indirect 1 1
Malaise 1 1
High Blood Pressure/ Hypertension 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Renal Failure 1 1
Cardiac Arrest 1 1
Septic Shock 1 1
Shock 1 1
Liver Failure 1 1

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