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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 1
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  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
2018 87 87
2019 64 64
2020 108 108
2021 77 77
2022 70 70
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 76 76
Fluid/Blood Leak 67 67
Material Integrity Problem 28 28
Adverse Event Without Identified Device or Use Problem 20 20
Insufficient Information 20 20
Leak/Splash 16 16
Nonstandard Device 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Deformation Due to Compressive Stress 14 14
Gas/Air Leak 12 12
Suction Problem 11 11
Infusion or Flow Problem 9 9
Break 8 8
Difficult to Remove 7 7
Appropriate Term/Code Not Available 7 7
Material Deformation 7 7
Noise, Audible 6 6
Thermal Decomposition of Device 6 6
Material Twisted/Bent 6 6
Component Missing 6 6
Obstruction of Flow 6 6
Contamination /Decontamination Problem 6 6
Defective Component 5 5
Device Operates Differently Than Expected 5 5
Coagulation in Device or Device Ingredient 5 5
Mechanical Problem 5 5
Improper or Incorrect Procedure or Method 5 5
No Apparent Adverse Event 5 5
Therapeutic or Diagnostic Output Failure 4 4
Material Puncture/Hole 4 4
Air Leak 4 4
Overfill 4 4
Defective Device 3 3
Detachment Of Device Component 3 3
Disconnection 3 3
Physical Resistance/Sticking 3 3
Excess Flow or Over-Infusion 2 2
Loose or Intermittent Connection 2 2
Device Alarm System 2 2
Burst Container or Vessel 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Kinked 2 2
Use of Device Problem 2 2
Self-Activation or Keying 2 2
Increase in Suction 2 2
Device Tipped Over 2 2
Device Displays Incorrect Message 2 2
Connection Problem 2 2
Detachment of Device or Device Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Inadequate Filtration Process 2 2
Insufficient Flow or Under Infusion 2 2
Difficult to Open or Close 2 2
Device Contamination with Chemical or Other Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Calibration Problem 1 1
Chemical Problem 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
Temperature Problem 1 1
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Device Markings/Labelling Problem 1 1
Blocked Connection 1 1
Device Inoperable 1 1
Inadequacy of Device Shape and/or Size 1 1
Smoking 1 1
Vibration 1 1
Volume Accuracy Problem 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Contamination 1 1
Decrease in Suction 1 1
Incorrect Measurement 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Inadequate Instructions for Healthcare Professional 1 1
Filling Problem 1 1
Fire 1 1
Sharp Edges 1 1
Device Fell 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unclear Information 1 1
Missing 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 123 123
No Known Impact Or Consequence To Patient 83 83
No Consequences Or Impact To Patient 51 51
No Patient Involvement 38 38
No Information 23 23
Insufficient Information 14 14
Unspecified Blood or Lymphatic problem 12 12
Death 11 11
Hemorrhage/Bleeding 11 11
Pneumothorax 9 9
Blood Loss 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Code Available 3 3
Foreign Body In Patient 3 3
Device Embedded In Tissue or Plaque 3 3
Low Oxygen Saturation 3 3
Hypovolemia 3 3
Therapeutic Response, Decreased 2 2
Respiratory Distress 2 2
Sepsis 2 2
Cardiac Arrest 2 2
Pleural Effusion 2 2
Low Blood Pressure/ Hypotension 2 2
Dyspnea 2 2
Pulmonary Embolism 2 2
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
Local Reaction 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Thrombus 1 1
Transient Ischemic Attack 1 1
Injury 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Blister 1 1

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