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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, autotransfusion
Product CodeCAC
Regulation Number 868.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 3
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PROCELL SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SISU GLOBAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 88 88
2018 87 87
2019 64 64
2020 108 108
2021 73 73
2022 65 65
2023 39 39
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 81 81
Crack 80 80
Material Integrity Problem 29 29
Adverse Event Without Identified Device or Use Problem 24 24
Infusion or Flow Problem 24 24
Insufficient Information 22 22
Leak/Splash 22 22
Mechanical Problem 19 19
Suction Problem 18 18
Nonstandard Device 15 15
Break 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Deformation Due to Compressive Stress 13 13
Obstruction of Flow 12 12
Gas/Air Leak 12 12
Material Deformation 11 11
Improper or Incorrect Procedure or Method 11 11
Air Leak 9 9
Material Puncture/Hole 8 8
Defective Component 8 8
Device Operates Differently Than Expected 8 8
Difficult to Remove 7 7
Component Missing 6 6
Thermal Decomposition of Device 6 6
Disconnection 6 6
Electrical /Electronic Property Problem 6 6
Connection Problem 6 6
Appropriate Term/Code Not Available 6 6
Noise, Audible 6 6
No Apparent Adverse Event 5 5
Detachment of Device or Device Component 5 5
Device Alarm System 5 5
Coagulation in Device or Device Ingredient 5 5
Tear, Rip or Hole in Device Packaging 5 5
Contamination /Decontamination Problem 5 5
Device Displays Incorrect Message 4 4
Overfill 4 4
Use of Device Problem 4 4
Detachment Of Device Component 4 4
Unsealed Device Packaging 4 4
Loose or Intermittent Connection 4 4
Material Twisted/Bent 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Difficult to Open or Close 3 3
Device Contamination with Chemical or Other Material 3 3
Therapeutic or Diagnostic Output Failure 3 3
Physical Resistance/Sticking 3 3
Excess Flow or Over-Infusion 3 3
Material Discolored 3 3
Vibration 3 3
Kinked 3 3
Smoking 3 3
Biocompatibility 3 3
Defective Device 3 3
Inadequate Filtration Process 2 2
Self-Activation or Keying 2 2
Device Inoperable 2 2
Insufficient Flow or Under Infusion 2 2
Fire 2 2
Burst Container or Vessel 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Optical Problem 2 2
Output Problem 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Temperature Problem 1 1
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Device Fell 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unclear Information 1 1
Device Markings/Labelling Problem 1 1
Device Packaging Compromised 1 1
Mechanics Altered 1 1
No Flow 1 1
No Pressure 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
Incorrect Measurement 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Moisture Damage 1 1
Partial Blockage 1 1
Contamination 1 1
Decrease in Suction 1 1
Disassembly 1 1
Fracture 1 1
Hole In Material 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Invalid Sensing 1 1
Microbial Contamination of Device 1 1
Volume Accuracy Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
No Known Impact Or Consequence To Patient 104 104
No Consequences Or Impact To Patient 71 71
No Patient Involvement 47 47
No Information 33 33
Hemorrhage/Bleeding 26 26
Blood Loss 20 20
Insufficient Information 14 14
Pneumothorax 13 13
Death 13 13
Unspecified Blood or Lymphatic problem 12 12
Device Embedded In Tissue or Plaque 7 7
Cardiac Arrest 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Code Available 4 4
Hypovolemia 4 4
Therapeutic Response, Decreased 3 3
Hemolysis 3 3
Not Applicable 3 3
Foreign Body In Patient 3 3
Low Oxygen Saturation 2 2
Respiratory Distress 2 2
Sepsis 2 2
Dyspnea 2 2
Pulmonary Embolism 2 2
Pleural Effusion 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Pain 1 1
Pneumonia 1 1
Hemothorax 1 1
Abscess 1 1
Adult Respiratory Distress Syndrome 1 1
Air Embolism 1 1
Bradycardia 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Thrombus 1 1
Transient Ischemic Attack 1 1
Injury 1 1
Impaired Healing 1 1
Reaction 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Local Reaction 1 1
Ruptured Aneurysm 1 1
Thrombosis/Thrombus 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Blister 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Dec-28-2023
2 Atrium Medical Corporation II Dec-02-2023
3 Atrium Medical Corporation II Nov-16-2023
4 Atrium Medical Corporation II Feb-15-2017
5 Fenwal Inc II Apr-23-2019
6 Fenwal Inc II Mar-26-2019
7 Haemonetics Corporation II Jan-29-2020
8 Haemonetics Corporation II Jan-28-2019
9 Haemonetics Corporation II Aug-30-2018
10 Maquet Cardiovascular, LLC I Jan-12-2024
11 Medtronic Perfusion Systems II Jan-29-2019
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