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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device separator for therapeutic purposes, membrane automated blood cell/plasma
Product CodeMDP
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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