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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
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 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 162 162
Crack 88 88
Mechanical Problem 49 49
Material Integrity Problem 29 29
Optical Problem 22 22
Obstruction of Flow 20 20
Material Deformation 20 20
Electrical /Electronic Property Problem 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 17 17
Noise, Audible 16 16
Device Alarm System 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Nonstandard Device 15 15
Leak/Splash 10 10
Material Puncture/Hole 8 8
Gas/Air Leak 6 6
Air/Gas in Device 6 6
Break 5 5
Suction Problem 5 5
Appropriate Term/Code Not Available 5 5
Smoking 4 4
Improper or Incorrect Procedure or Method 4 4
Material Twisted/Bent 4 4
Infusion or Flow Problem 3 3
Detachment of Device or Device Component 3 11
Connection Problem 3 3
Contamination /Decontamination Problem 3 3
Defective Device 3 3
Delivered as Unsterile Product 3 3
No Apparent Adverse Event 3 3
Therapeutic or Diagnostic Output Failure 3 3
Disconnection 3 3
Material Discolored 3 3
Loose or Intermittent Connection 2 2
Use of Device Problem 2 2
Material Separation 2 2
Fracture 2 2
Contamination 2 2
Burst Container or Vessel 2 2
Temperature Problem 1 1
Pressure Problem 1 1
No Pressure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Body Fluid 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 282 290
Hemorrhage/Bleeding 98 98
No Known Impact Or Consequence To Patient 41 41
Insufficient Information 17 17
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
Death 5 5
Hypovolemia 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 3 3
Bradycardia 2 2
Thrombosis/Thrombus 2 2
Pleural Effusion 2 2
Renal Failure 2 2
Respiratory Distress 2 2
Pulmonary Embolism 1 1
Air Embolism 1 1
Anemia 1 1
Cardiac Arrest 1 1
Myocardial Contusion 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
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 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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