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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 3
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PROCELL SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SISU GLOBAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 88 88
2018 87 87
2019 64 64
2020 108 108
2021 77 77
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 78 78
Fluid/Blood Leak 73 73
Adverse Event Without Identified Device or Use Problem 24 24
Infusion or Flow Problem 23 23
Material Integrity Problem 22 22
Insufficient Information 22 22
Leak/Splash 22 22
Suction Problem 18 18
Break 15 15
Deformation Due to Compressive Stress 14 14
Gas/Air Leak 12 12
Improper or Incorrect Procedure or Method 11 11
Air Leak 9 9
Defective Component 8 8
Device Operates Differently Than Expected 8 8
Material Deformation 7 7
Component Missing 7 7
Difficult to Remove 7 7
Thermal Decomposition of Device 6 6
Disconnection 6 6
Obstruction of Flow 6 6
Contamination /Decontamination Problem 6 6
Connection Problem 6 6
Material Twisted/Bent 6 6
Appropriate Term/Code Not Available 6 6
Noise, Audible 5 5
Tear, Rip or Hole in Device Packaging 5 5
Coagulation in Device or Device Ingredient 5 5
Detachment Of Device Component 4 4
Loose or Intermittent Connection 4 4
Unsealed Device Packaging 4 4
Material Puncture/Hole 4 4
Overfill 4 4
Detachment of Device or Device Component 4 4
Device Displays Incorrect Message 4 4
Therapeutic or Diagnostic Output Failure 4 4
No Apparent Adverse Event 4 4
Physical Resistance/Sticking 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Difficult to Open or Close 3 3
Device Contamination with Chemical or Other Material 3 3
Biocompatibility 3 3
Defective Device 3 3
Use of Device Problem 3 3
Vibration 3 3
Mechanical Problem 3 3
Excess Flow or Over-Infusion 3 3
Kinked 3 3
Fire 2 2
Burst Container or Vessel 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Increase in Suction 2 2
Self-Activation or Keying 2 2
Inadequate Filtration Process 2 2
Device Inoperable 2 2
Insufficient Flow or Under Infusion 2 2
Device Tipped Over 2 2
Incorrect Or Inadequate Test Results 1 1
Invalid Sensing 1 1
Microbial Contamination of Device 1 1
Blocked Connection 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Device Markings/Labelling Problem 1 1
Out-Of-Box Failure 1 1
Device Contamination with Body Fluid 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Inadequate or Insufficient Training 1 1
Volume Accuracy Problem 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Moisture Damage 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Incorrect Measurement 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Alarm System 1 1
Partial Blockage 1 1
Contamination 1 1
Decrease in Suction 1 1
Disassembly 1 1
Inadequate Instructions for Healthcare Professional 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Hole In Material 1 1
Device Packaging Compromised 1 1
Mechanics Altered 1 1
No Flow 1 1
No Pressure 1 1
Output Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 104 104
No Clinical Signs, Symptoms or Conditions 96 96
No Consequences Or Impact To Patient 71 71
No Patient Involvement 47 47
No Information 33 33
Blood Loss 20 20
Pneumothorax 14 14
Death 13 13
Insufficient Information 13 13
Unspecified Blood or Lymphatic problem 11 11
Hemorrhage/Bleeding 10 10
Device Embedded In Tissue or Plaque 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Cardiac Arrest 5 5
No Code Available 4 4
Not Applicable 3 3
Foreign Body In Patient 3 3
Low Oxygen Saturation 3 3
Hypovolemia 3 3
Therapeutic Response, Decreased 3 3
Respiratory Distress 2 2
Sepsis 2 2
Pleural Effusion 2 2
Low Blood Pressure/ Hypotension 2 2
Dyspnea 2 2
Pulmonary Embolism 2 2
Abscess 1 1
Adult Respiratory Distress Syndrome 1 1
Air Embolism 1 1
Bradycardia 1 1
Hemolysis 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Pain 1 1
Pneumonia 1 1
Hemothorax 1 1
Thrombus 1 1
Transient Ischemic Attack 1 1
Injury 1 1
Impaired Healing 1 1
Reaction 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Local Reaction 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Blister 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Feb-15-2017
2 Fenwal Inc II Apr-23-2019
3 Fenwal Inc II Mar-26-2019
4 Haemonetics Corporation II Jan-29-2020
5 Haemonetics Corporation II Jan-28-2019
6 Haemonetics Corporation II Aug-30-2018
7 Medtronic Perfusion Systems II Jan-29-2019
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