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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, autotransfusion
Regulation Description Autotransfusion apparatus.
Product CodeCAC
Regulation Number 868.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INQUIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240426  Aventus Clot Management System
PROCELL SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SISU GLOBAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 108 108
2021 73 73
2022 65 65
2023 39 39
2024 132 140
2025 17 37

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 138 138
Crack 85 85
Mechanical Problem 44 44
Material Integrity Problem 29 29
Obstruction of Flow 19 19
Insufficient Information 17 17
Optical Problem 16 16
Electrical /Electronic Property Problem 16 16
Material Deformation 15 15
Nonstandard Device 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Device Alarm System 14 14
Leak/Splash 10 10
Noise, Audible 10 10
Material Puncture/Hole 7 7
Gas/Air Leak 6 6
Suction Problem 5 5
Air/Gas in Device 5 5
Appropriate Term/Code Not Available 5 5
Material Twisted/Bent 4 4
Smoking 4 4
Improper or Incorrect Procedure or Method 4 4
Contamination /Decontamination Problem 3 3
Infusion or Flow Problem 3 3
No Apparent Adverse Event 3 3
Material Discolored 3 3
Delivered as Unsterile Product 3 3
Therapeutic or Diagnostic Output Failure 3 3
Disconnection 3 3
Break 3 3
Connection Problem 3 3
Defective Device 3 3
Detachment of Device or Device Component 3 31
Fracture 2 2
Loose or Intermittent Connection 2 2
Contamination 2 2
Use of Device Problem 2 2
Burst Container or Vessel 2 2
Free or Unrestricted Flow 1 1
Device Contamination with Body Fluid 1 1
Microbial Contamination of Device 1 1
Unsealed Device Packaging 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Calibration Problem 1 1
Material Separation 1 1
Sharp Edges 1 1
Inadequacy of Device Shape and/or Size 1 1
Increase in Suction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 250 278
Hemorrhage/Bleeding 81 81
No Known Impact Or Consequence To Patient 41 41
Insufficient Information 15 15
No Consequences Or Impact To Patient 14 14
Unspecified Blood or Lymphatic problem 12 12
No Patient Involvement 11 11
Blood Loss 6 6
No Information 6 6
Hypovolemia 5 5
Death 5 5
Hemolysis 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pneumothorax 3 3
Low Cardiac Output 2 2
Bradycardia 2 2
Thrombosis/Thrombus 2 2
Pleural Effusion 2 2
Respiratory Distress 2 2
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Anemia 1 1
Cardiac Arrest 1 1
Hemothorax 1 1
Unspecified Infection 1 1
Inflammation 1 1
Blister 1 1
Ruptured Aneurysm 1 1
Unspecified Heart Problem 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Local Reaction 1 1
Renal Failure 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 Haemonetics Corporation II Jan-29-2020
5 Maquet Cardiovascular, LLC I Jan-12-2024
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