Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
extracorporeal system for long-term respiratory / cardiopulmonary failure
Definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Product Code
QJZ
Regulation Number
870.4100
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
-
-