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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device organ care system (ocs) heart system
Definition A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.
Product CodeQIK
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 1 3 2 2 0

MDR Year MDR Reports MDR Events
2024 11 11
2025 5 5
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 3 3
Fluid/Blood Leak 3 3
Communication or Transmission Problem 2 2
Defective Device 2 2
Filtration Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Infusion or Flow Problem 1 1
Misconnection 1 1
Detachment of Device or Device Component 1 1
Insufficient Heating 1 1
Connection Problem 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Heart Failure/Congestive Heart Failure 2 2
Insufficient Information 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Unspecified Infection 1 1
Memory Loss/Impairment 1 1
Cardiovascular Insufficiency 1 1

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