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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, autotransfusion
Regulation Description Autotransfusion apparatus.
Product CodeCAC
Regulation Number 868.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 4
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PROCELL SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SISU GLOBAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
TLELFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2011 939 939
2012 249 249
2013 153 153
2014 90 90
2015 87 87
2016 73 73
2017 88 88
2018 87 87
2019 64 64
2020 108 108
2021 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Body Fluid 333 333
Fluid Leak 178 178
Nonstandard Device 162 162
Device Operates Differently Than Expected 137 137
Break 114 114
Leak/Splash 114 114
Failure to Power Up 103 103
Loss of Power 85 85
Crack 84 84
Insufficient Information 84 84
Device Displays Incorrect Message 78 78
Device Emits Odor 74 74
Noise, Audible 55 55
Moisture Damage 54 54
Device Inoperable 50 50
Infusion or Flow Problem 49 49
Suction Problem 45 45
Detachment Of Device Component 45 45
Disconnection 40 40
Electrical Shorting 38 38
Appropriate Term/Code Not Available 35 35
Smoking 34 34
Failure to Charge 29 29
Air Leak 28 28
Adverse Event Without Identified Device or Use Problem 27 27
Contamination 20 20
Device Maintenance Issue 20 20
Difficult to Remove 19 19
Other (for use when an appropriate device code cannot be identified) 17 17
Coagulation in Device or Device Ingredient 16 16
Improper or Incorrect Procedure or Method 16 16
Occlusion Within Device 14 14
Deformation Due to Compressive Stress 13 13
Component Missing 10 10
Hole In Material 10 10
Gas Leak 10 10
Thermal Decomposition of Device 10 10
Device Alarm System 9 9
Decrease in Suction 9 9
Material Rupture 9 9
Loose or Intermittent Connection 9 9
Defective Component 9 9
Connection Problem 9 9
Kinked 8 8
Decrease in Pressure 8 8
Inadequate Filtration Process 7 7
Mechanical Jam 7 7
No Flow 7 7
Burst Container or Vessel 7 7
Material Puncture/Hole 7 7
Sparking 7 7
Device Slipped 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Integrity Problem 6 6
Material Deformation 5 5
Optical Problem 5 5
Contamination /Decontamination Problem 5 5
Charging Problem 5 5
Battery Problem 5 5
Failure to Infuse 5 5
Insufficient Flow or Under Infusion 5 5
Circuit Failure 5 5
Overfill 5 5
Disassembly 5 5
Unsealed Device Packaging 4 4
Defective Device 4 4
Use of Device Problem 4 4
Visual Prompts will not Clear 4 4
Difficult to Open or Close 4 4
Detachment of Device or Device Component 4 4
No Apparent Adverse Event 4 4
Component Falling 4 4
Electrical /Electronic Property Problem 4 4
Poor Quality Image 4 4
Sticking 4 4
Biocompatibility 4 4
Device Contamination with Chemical or Other Material 4 4
Chemical Spillage 3 3
Reflux within Device 3 3
Performance 3 3
Vibration 3 3
Misconnection 3 3
Self-Activation or Keying 3 3
Physical Resistance/Sticking 3 3
Therapeutic or Diagnostic Output Failure 3 3
Torn Material 3 3
Device Packaging Compromised 3 3
Device Dislodged or Dislocated 3 3
Obstruction of Flow 3 3
Structural Problem 3 3
Device Issue 3 3
Physical Resistance 3 3
Excess Flow or Over-Infusion 3 3
No Display/Image 3 3
Fire 3 3
Complete Blockage 3 3
Bent 2 2
Material Fragmentation 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1126 1126
No Consequences Or Impact To Patient 392 392
No Information 98 98
Blood Loss 55 55
No Patient Involvement 51 51
No Clinical Signs, Symptoms or Conditions 45 45
No Code Available 38 38
Pneumothorax 28 28
Death 23 23
Hemorrhage/Bleeding 15 15
Device Embedded In Tissue or Plaque 14 14
Foreign Body In Patient 11 11
Insufficient Information 9 9
Unspecified Blood or Lymphatic problem 8 8
No Patient involvement 7 7
Cardiac Arrest 7 7
Test Result 6 6
Low Blood Pressure/ Hypotension 6 6
Exposure to Body Fluids 5 5
Pain 5 5
Pleural Effusion 4 4
Therapeutic Response, Decreased 4 4
Complaint, Ill-Defined 4 4
Not Applicable 3 3
Reaction 3 3
Apheresis 3 3
Hemolysis 3 3
Air Embolism 3 3
Thrombus 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hematoma 3 3
Other (for use when an appropriate patient code cannot be identified) 3 3
Low Oxygen Saturation 2 2
Underdose 2 2
Hematuria 2 2
Cardiopulmonary Arrest 2 2
Dyspnea 2 2
Fall 2 2
Sepsis 2 2
Swelling 2 2
Pulmonary Embolism 2 2
Respiratory Distress 2 2
Seizures 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Venipuncture 1 1
Dizziness 1 1
Brain Injury 1 1
Injury 1 1
Impaired Healing 1 1
Needle Stick/Puncture 1 1
Chest Tightness/Pressure 1 1
Abdominal Pain 1 1
Adult Respiratory Distress Syndrome 1 1
Chest Pain 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Pneumonia 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Hemothorax 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Blister 1 1
Abrasion 1 1
Abscess 1 1
Anemia 1 1
Burn(s) 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Therapeutic Effects, Unexpected 1 1
Thrombosis 1 1
Transient Ischemic Attack 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Rupture 1 1
Extubate 1 1
Loss of consciousness 1 1
Vascular Dissection 1 1
Lead(s), Burn(s) From 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Feb-15-2017
2 Atrium Medical Corporation II Jul-01-2014
3 Atrium Medical Corporation II Jan-14-2014
4 Fenwal Inc II Apr-23-2019
5 Fenwal Inc II Mar-26-2019
6 Fresenius Kabi, LLC II Nov-10-2010
7 Haemonetics Corporation II Jan-29-2020
8 Haemonetics Corporation II Jan-28-2019
9 Haemonetics Corporation II Aug-30-2018
10 Haemonetics Corporation II Aug-05-2011
11 Haemonetics Corporation II Jun-07-2011
12 Haemonetics Corporation II Feb-22-2011
13 Medtronic Perfusion Systems II Jan-29-2019
14 Stryker Instruments Div. of Stryker Corporation II May-01-2015
15 Stryker Instruments Div. of Stryker Corporation II Jan-29-2010
16 Teleflex Medical II Apr-28-2016
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