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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extracorporeal system for long-term respiratory / cardiopulmonary failure
Definition Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Product CodeQJZ
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 17 17
2021 52 52
2022 53 53
2023 104 104
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 145 145
Communication or Transmission Problem 80 80
Adverse Event Without Identified Device or Use Problem 35 35
Improper Flow or Infusion 5 5
Obstruction of Flow 4 4
Insufficient Flow or Under Infusion 3 3
Pressure Problem 2 2
Melted 2 2
Thermal Decomposition of Device 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 171 171
Hemorrhage/Bleeding 51 51
Hemolysis 18 18
No Patient Involvement 12 12
Cardiac Arrest 7 7
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 4 4
Viral Infection 4 4
Hemolytic Anemia 3 3
Respiratory Failure 3 3
Brain Injury 2 2
Thrombosis/Thrombus 2 2
Cardiogenic Shock 2 2
Low Blood Pressure/ Hypotension 2 2
Low Oxygen Saturation 2 2
Death 1 1
Abnormal Blood Gases 1 1
Blood Loss 1 1
Cardiopulmonary Arrest 1 1
Heart Failure/Congestive Heart Failure 1 1
Embolism 1 1
Thrombocytopenia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II May-15-2024
2 Fresenius Medical Care Holdings, Inc. II Feb-04-2022
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