• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 92 92
Crack 79 79
Mechanical Problem 31 31
Material Integrity Problem 29 29
Insufficient Information 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Obstruction of Flow 15 15
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 10 10
Electrical /Electronic Property Problem 10 10
Noise, Audible 8 8
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
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
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 198 198
No Known Impact Or Consequence To Patient 60 60
Hemorrhage/Bleeding 46 46
No Patient Involvement 31 31
No Consequences Or Impact To Patient 29 29
Insufficient Information 15 15
Unspecified Blood or Lymphatic problem 12 12
Death 8 8
No Information 8 8
Blood Loss 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hypovolemia 5 5
Pneumothorax 3 3
Hemolysis 3 3
Cardiac Arrest 3 3
Respiratory Distress 2 2
Low Cardiac Output 2 2
Foreign Body In Patient 2 2
Thrombosis/Thrombus 2 2
Pleural Effusion 2 2
Low Blood Pressure/ Hypotension 2 2
Air Embolism 1 1
Unspecified Infection 1 1
No Code Available 1 1
Local Reaction 1 1
Cognitive Changes 1 1
Blister 1 1
Dyspnea 1 1
Bradycardia 1 1
Renal Failure 1 1
Sudden Cardiac Death 1 1
Cough 1 1
Skin Tears 1 1
Ruptured Aneurysm 1 1
Unspecified Heart Problem 1 1
Hemothorax 1 1
Thrombus 1 1
Low Oxygen Saturation 1 1
Pulmonary Embolism 1 1
Aspiration Pneumonitis 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
-
-