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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 1

MDR Year MDR Reports MDR Events
2019 64 64
2020 108 108
2021 73 73
2022 65 65
2023 39 39
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 76 76
Fluid/Blood Leak 69 69
Material Integrity Problem 29 29
Mechanical Problem 24 24
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 13 13
Deformation Due to Compressive Stress 13 13
Leak/Splash 12 12
Material Deformation 11 11
Gas/Air Leak 8 8
Material Puncture/Hole 8 8
Electrical /Electronic Property Problem 7 7
Suction Problem 6 6
Appropriate Term/Code Not Available 6 6
Contamination /Decontamination Problem 5 5
Infusion or Flow Problem 5 5
No Apparent Adverse Event 5 5
Device Alarm System 5 5
Break 4 4
Improper or Incorrect Procedure or Method 4 4
Material Twisted/Bent 4 4
Noise, Audible 4 4
Physical Resistance/Sticking 3 3
Therapeutic or Diagnostic Output Failure 3 3
Component Missing 3 3
Defective Device 3 3
Material Discolored 3 3
Disconnection 3 3
Thermal Decomposition of Device 2 2
Burst Container or Vessel 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Self-Activation or Keying 2 2
Smoking 2 2
Use of Device Problem 2 2
Defective Component 2 2
Connection Problem 2 2
Optical Problem 2 2
Output Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
No Pressure 1 1
No Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 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
Volume Accuracy Problem 1 1
Increase in Suction 1 1
Inadequacy of Device Shape and/or Size 1 1
Misconnection 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
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
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 161 161
No Known Impact Or Consequence To Patient 60 60
No Patient Involvement 31 31
No Consequences Or Impact To Patient 29 29
Hemorrhage/Bleeding 26 26
Insufficient Information 14 14
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
Thrombosis/Thrombus 2 2
Pleural Effusion 2 2
Respiratory Distress 2 2
Foreign Body In Patient 2 2
No Code Available 1 1
Thrombus 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Blister 1 1
Ruptured Aneurysm 1 1
Unspecified Infection 1 1
Local Reaction 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 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
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