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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 4
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INQUIS 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 5
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
TLELFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 90 90
2015 87 87
2016 73 73
2017 88 88
2018 87 87
2019 64 64
2020 108 108
2021 73 73
2022 65 65
2023 39 39
2024 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 124 124
Crack 92 92
Leak/Splash 50 50
Infusion or Flow Problem 40 40
Device Operates Differently Than Expected 39 39
Insufficient Information 35 35
Suction Problem 34 34
Break 33 33
Material Integrity Problem 31 31
Adverse Event Without Identified Device or Use Problem 30 30
Mechanical Problem 30 30
Nonstandard Device 25 25
Disconnection 23 23
Air Leak 18 18
Obstruction of Flow 16 16
Device Misassembled During Manufacturing /Shipping 15 15
Improper or Incorrect Procedure or Method 14 14
Noise, Audible 13 13
Deformation Due to Compressive Stress 13 13
Material Deformation 13 13
Gas/Air Leak 12 12
Coagulation in Device or Device Ingredient 12 12
Other (for use when an appropriate device code cannot be identified) 11 11
Device Displays Incorrect Message 10 10
Detachment Of Device Component 9 9
Difficult to Remove 9 9
Appropriate Term/Code Not Available 9 9
Optical Problem 9 9
Device Alarm System 9 9
Material Puncture/Hole 9 9
Defective Component 8 8
Connection Problem 8 8
Component Missing 8 8
Decrease in Pressure 8 8
Electrical /Electronic Property Problem 7 7
Device Inoperable 6 6
Thermal Decomposition of Device 6 6
Tear, Rip or Hole in Device Packaging 5 5
Use of Device Problem 5 5
Contamination /Decontamination Problem 5 5
Detachment of Device or Device Component 5 5
No Apparent Adverse Event 5 5
Smoking 5 5
Kinked 5 5
Loose or Intermittent Connection 5 5
Device Contamination with Body Fluid 5 5
Defective Device 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Contamination with Chemical or Other Material 4 4
Unsealed Device Packaging 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 184 184
No Known Impact Or Consequence To Patient 182 182
No Consequences Or Impact To Patient 141 141
No Information 64 64
No Patient Involvement 48 48
Hemorrhage/Bleeding 45 45
Blood Loss 30 30
Pneumothorax 25 25
No Code Available 19 19
Death 16 16
Insufficient Information 15 15
Device Embedded In Tissue or Plaque 12 12
Unspecified Blood or Lymphatic problem 12 12
Cardiac Arrest 6 6
Foreign Body In Patient 6 6
Hypovolemia 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Complaint, Ill-Defined 4 4
Hemolysis 4 4
Low Blood Pressure/ Hypotension 4 4
Therapeutic Response, Decreased 4 4
Pleural Effusion 4 4
Low Oxygen Saturation 3 3
Not Applicable 3 3
Pain 3 3
Pulmonary Embolism 2 2
Respiratory Distress 2 2
Sepsis 2 2
Reaction 2 2
Hematoma 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2
Low Cardiac Output 2 2
Dyspnea 2 2
Thrombosis/Thrombus 2 2
Exposure to Body Fluids 2 2
Renal Failure 1 1
Sudden Cardiac Death 1 1
Cough 1 1
Hypoxia 1 1
Skin Tears 1 1
Ruptured Aneurysm 1 1
Unspecified Heart Problem 1 1
Therapeutic Effects, Unexpected 1 1
Extubate 1 1
Loss of consciousness 1 1
Lead(s), Burn(s) From 1 1
Hemothorax 1 1
Thrombus 1 1
Aspiration Pneumonitis 1 1
Pulmonary Edema 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 Atrium Medical Corporation II Feb-15-2017
5 Atrium Medical Corporation II Jul-01-2014
6 Atrium Medical Corporation II Jan-14-2014
7 Fenwal Inc II Apr-23-2019
8 Fenwal Inc II Mar-26-2019
9 Fresenius Kabi, LLC II Nov-10-2010
10 Haemonetics Corporation II Jan-29-2020
11 Haemonetics Corporation II Jan-28-2019
12 Haemonetics Corporation II Aug-30-2018
13 Haemonetics Corporation II Aug-05-2011
14 Haemonetics Corporation II Jun-07-2011
15 Haemonetics Corporation II Feb-22-2011
16 Maquet Cardiovascular, LLC I Jan-12-2024
17 Medtronic Perfusion Systems II Jan-29-2019
18 Stryker Instruments Div. of Stryker Corporation II May-01-2015
19 Stryker Instruments Div. of Stryker Corporation II Jan-29-2010
20 Teleflex Medical II Apr-28-2016
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