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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 2
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
2019 64 64
2020 108 108
2021 73 73
2022 65 65
2023 39 39
2024 90 104

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 96 96
Crack 80 80
Mechanical Problem 36 36
Material Integrity Problem 29 29
Insufficient Information 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Obstruction of Flow 16 16
Device Misassembled During Manufacturing /Shipping 15 15
Nonstandard Device 15 15
Material Deformation 14 14
Deformation Due to Compressive Stress 13 13
Leak/Splash 12 12
Optical Problem 12 12
Electrical /Electronic Property Problem 12 12
Noise, Audible 10 10
Gas/Air Leak 8 8
Device Alarm System 8 8
Material Puncture/Hole 8 8
Appropriate Term/Code Not Available 8 8
Suction Problem 6 6
Infusion or Flow Problem 5 5
No Apparent Adverse Event 5 5
Contamination /Decontamination Problem 5 5
Break 4 4
Improper or Incorrect Procedure or Method 4 4
Material Twisted/Bent 4 4
Delivered as Unsterile Product 3 3
Component Missing 3 3
Material Discolored 3 3
Air/Gas in Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Smoking 3 3
Connection Problem 3 3
Physical Resistance/Sticking 3 3
Disconnection 3 3
Contamination 2 2
Fracture 2 2
Defective Component 2 2
Use of Device Problem 2 2
Self-Activation or Keying 2 2
Loose or Intermittent Connection 2 2
Thermal Decomposition of Device 2 2
Detachment of Device or Device Component 2 16
Burst Container or Vessel 2 2
Application Program Freezes, Becomes Nonfunctional 1 1
Protective Measures Problem 1 1
Free or Unrestricted Flow 1 1
Overheating of Device 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 209 223
No Known Impact Or Consequence To Patient 60 60
Hemorrhage/Bleeding 51 51
No Patient Involvement 31 31
No Consequences Or Impact To Patient 29 29
Insufficient Information 15 15
Unspecified Blood or Lymphatic problem 12 12
No Information 8 8
Death 8 8
Blood Loss 7 7
Hypovolemia 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cardiac Arrest 3 3
Hemolysis 3 3
Pneumothorax 3 3
Respiratory Distress 2 2
Low Blood Pressure/ Hypotension 2 2
Pleural Effusion 2 2
Low Cardiac Output 2 2
Foreign Body In Patient 2 2
Thrombosis/Thrombus 2 2
Unspecified Heart Problem 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Blister 1 1
No Code Available 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Low Oxygen Saturation 1 1
Unspecified Infection 1 1
Hemothorax 1 1
Thrombus 1 1
Local Reaction 1 1
Renal Failure 1 1
Dyspnea 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Ruptured Aneurysm 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 Fenwal Inc II Apr-23-2019
5 Fenwal Inc II Mar-26-2019
6 Haemonetics Corporation II Jan-29-2020
7 Haemonetics Corporation II Jan-28-2019
8 Maquet Cardiovascular, LLC I Jan-12-2024
9 Medtronic Perfusion Systems II Jan-29-2019
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