Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 1

MDR Year MDR Reports MDR Events
2019 64 64
2020 108 108
2021 73 73
2022 65 65
2023 39 39
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 76 76
Fluid/Blood Leak 73 73
Material Integrity Problem 29 29
Mechanical Problem 26 26
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 17 17
Device Misassembled During Manufacturing /Shipping 15 15
Nonstandard Device 15 15
Obstruction of Flow 14 14
Deformation Due to Compressive Stress 13 13
Material Deformation 12 12
Leak/Splash 12 12
Optical Problem 9 9
Gas/Air Leak 8 8
Material Puncture/Hole 8 8
Appropriate Term/Code Not Available 8 8
Electrical /Electronic Property Problem 7 7
Device Alarm System 6 6
Suction Problem 6 6
Noise, Audible 6 6
Contamination /Decontamination Problem 5 5
Infusion or Flow Problem 5 5
No Apparent Adverse Event 5 5
Improper or Incorrect Procedure or Method 4 4
Material Twisted/Bent 4 4
Break 4 4
Material Discolored 3 3
Disconnection 3 3
Smoking 3 3
Therapeutic or Diagnostic Output Failure 3 3
Component Missing 3 3
Defective Device 3 3
Physical Resistance/Sticking 3 3
Defective Component 2 2
Connection Problem 2 2
Use of Device Problem 2 2
Self-Activation or Keying 2 2
Delivered as Unsterile Product 2 2
Thermal Decomposition of Device 2 2
Burst Container or Vessel 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 1 1
Filling Problem 1 1
Fracture 1 1
Excess Flow or Over-Infusion 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination 1 1
Decrease in Suction 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
Misconnection 1 1
Volume Accuracy Problem 1 1
Increase in Suction 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Body Fluid 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Microbial Contamination of Device 1 1
Insufficient Flow or Under Infusion 1 1
Device Displays Incorrect Message 1 1
Blocked Connection 1 1
No Pressure 1 1
Output Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
No Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Sharp Edges 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unclear Information 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 168 168
No Known Impact Or Consequence To Patient 60 60
Hemorrhage/Bleeding 34 34
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hypovolemia 4 4
Pneumothorax 3 3
Cardiac Arrest 3 3
Hemolysis 3 3
Low Blood Pressure/ Hypotension 2 2
Respiratory Distress 2 2
Pleural Effusion 2 2
Foreign Body In Patient 2 2
Low Cardiac Output 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
Ruptured Aneurysm 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Thrombus 1 1
Low Oxygen Saturation 1 1
Unspecified Infection 1 1
Local Reaction 1 1
Hemothorax 1 1
Dyspnea 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Bradycardia 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
-
-