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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary non-roller type right heart support blood pump
Definition Providing temporary partial or full right heart circulatory support.
Product CodePYX
Regulation Number 870.4360
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
7 10 8 8 13 2

MDR Year MDR Reports MDR Events
2018 10 10
2019 10 10
2020 10 10
2021 7 7
2022 9 9
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23 23
Insufficient Information 8 8
Break 4 4
Material Separation 4 4
Physical Resistance/Sticking 3 3
Appropriate Term/Code Not Available 2 2
Material Twisted/Bent 2 2
Material Split, Cut or Torn 1 1
Unexpected Shutdown 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Use of Device Problem 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1
Difficult To Position 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemolysis 12 12
Blood Loss 11 11
Hemorrhage/Bleeding 8 8
Device Embedded In Tissue or Plaque 6 6
Perforation 3 3
Perforation of Vessels 3 3
Patient Problem/Medical Problem 2 2
Hematoma 2 2
Vascular Dissection 2 2
No Code Available 2 2
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Insufficient Information 1 1
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1
Cardiac Perforation 1 1
Abdominal Distention 1 1
Hypervolemia 1 1
Thrombus 1 1
Venipuncture 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Infiltration into Tissue 1 1
Liver Damage/Dysfunction 1 1

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