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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
separator for therapeutic purposes, membrane automated blood cell/plasma
Product Code
MDP
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
1
2
3
0
0
0
3
2
1
2
2
4
4
5
3
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
5
5
2016
13
13
2017
14
14
2018
13
13
2019
13
13
2020
8
8
2021
10
10
2022
8
8
2023
16
16
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
46
46
Fluid/Blood Leak
31
31
Leak/Splash
8
8
Patient-Device Incompatibility
8
8
Crack
5
5
Break
5
5
Biocompatibility
5
5
Insufficient Information
2
2
No Apparent Adverse Event
2
2
No Display/Image
1
1
Obstruction of Flow
1
1
Material Puncture/Hole
1
1
Smoking
1
1
Coagulation in Device or Device Ingredient
1
1
Misassembled
1
1
Defective Device
1
1
Overheating of Device
1
1
Detachment of Device or Device Component
1
1
Material Rupture
1
1
Thermal Decomposition of Device
1
1
Air/Gas in Device
1
1
Complete Blockage
1
1
Air Leak
1
1
Hole In Material
1
1
Device Emits Odor
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
28
28
Pain
14
14
Hypersensitivity/Allergic reaction
10
10
Low Blood Pressure/ Hypotension
10
10
No Known Impact Or Consequence To Patient
9
9
Blood Loss
8
8
Nausea
7
7
No Consequences Or Impact To Patient
7
7
Respiratory Distress
5
5
Anaphylactic Shock
5
5
Dyspnea
3
3
Renal Disease, End Stage
3
3
Shock
3
3
First Use Syndrome
3
3
Malaise
3
3
Patient Problem/Medical Problem
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Erythema
2
2
Bradycardia
2
2
Cardiac Arrest
1
1
Chest Pain
1
1
Dehydration
1
1
Headache
1
1
Hemolysis
1
1
Itching Sensation
1
1
Liver Damage/Dysfunction
1
1
Hyperthermia
1
1
Pneumonia
1
1
Pulmonary Edema
1
1
Rash
1
1
Loss of consciousness
1
1
Chest Tightness/Pressure
1
1
Low Oxygen Saturation
1
1
Shaking/Tremors
1
1
Urticaria
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Tachycardia
1
1
Vomiting
1
1
Hot Flashes/Flushes
1
1
Tingling
1
1
Chills
1
1
Seizures
1
1
No Patient Involvement
1
1
No Information
1
1
Breast Discomfort/Pain
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Gambro Renal Products, Incorporated
II
Aug-13-2014
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