Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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
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 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 112 112
Crack 90 90
Leak/Splash 50 50
Infusion or Flow Problem 40 40
Device Operates Differently Than Expected 39 39
Insufficient Information 34 34
Suction Problem 34 34
Break 33 33
Material Integrity Problem 31 31
Adverse Event Without Identified Device or Use Problem 30 30
Nonstandard Device 25 25
Disconnection 23 23
Mechanical Problem 19 19
Air Leak 18 18
Device Misassembled During Manufacturing /Shipping 15 15
Improper or Incorrect Procedure or Method 14 14
Obstruction of Flow 13 13
Deformation Due to Compressive Stress 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
Material Deformation 11 11
Device Displays Incorrect Message 10 10
Noise, Audible 9 9
Material Puncture/Hole 9 9
Difficult to Remove 9 9
Detachment Of Device Component 9 9
Decrease in Pressure 8 8
Defective Component 8 8
Component Missing 8 8
Appropriate Term/Code Not Available 7 7
Connection Problem 7 7
Device Inoperable 6 6
Thermal Decomposition of Device 6 6
Device Alarm System 6 6
Electrical /Electronic Property Problem 6 6
Loose or Intermittent Connection 5 5
Use of Device Problem 5 5
Kinked 5 5
Detachment of Device or Device Component 5 5
Contamination /Decontamination Problem 5 5
Device Contamination with Body Fluid 5 5
Tear, Rip or Hole in Device Packaging 5 5
No Apparent Adverse Event 5 5
No Flow 4 4
Material Twisted/Bent 4 4
Therapeutic or Diagnostic Output Failure 4 4
Overfill 4 4
Defective Device 4 4
Difficult to Open or Close 4 4
Device Contamination with Chemical or Other Material 4 4
Unsealed Device Packaging 4 4
Smoking 4 4
Inadequate Filtration Process 4 4
Insufficient Flow or Under Infusion 4 4
Hole In Material 4 4
Disassembly 4 4
Material Discolored 3 3
Excess Flow or Over-Infusion 3 3
Decrease in Suction 3 3
Burst Container or Vessel 3 3
Vibration 3 3
Failure to Power Up 3 3
Device Emits Odor 3 3
Device Slipped 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Issue 3 3
Biocompatibility 3 3
Physical Resistance/Sticking 3 3
Pressure Problem 2 2
Optical Problem 2 2
Improper Device Output 2 2
Device Packaging Compromised 2 2
Computer Operating System Problem 2 2
Self-Activation or Keying 2 2
Device Stops Intermittently 2 2
Out-Of-Box Failure 2 2
Entrapment of Device 2 2
Fracture 2 2
Partial Blockage 2 2
Fire 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Misconnection 2 2
Moisture Damage 1 1
Incorrect Measurement 1 1
Migration or Expulsion of Device 1 1
Material Fragmentation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Bent 1 1
Failure to Charge 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Invalid Sensing 1 1
Microbial Contamination of Device 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Increase in Suction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 182 182
No Clinical Signs, Symptoms or Conditions 155 155
No Consequences Or Impact To Patient 141 141
No Information 64 64
No Patient Involvement 48 48
Blood Loss 30 30
Hemorrhage/Bleeding 27 27
Pneumothorax 25 25
No Code Available 19 19
Death 16 16
Insufficient Information 14 14
Device Embedded In Tissue or Plaque 12 12
Unspecified Blood or Lymphatic problem 12 12
Foreign Body In Patient 6 6
Cardiac Arrest 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hypovolemia 4 4
Therapeutic Response, Decreased 4 4
Complaint, Ill-Defined 4 4
Low Blood Pressure/ Hypotension 4 4
Hemolysis 4 4
Pleural Effusion 4 4
Pain 3 3
Low Oxygen Saturation 3 3
Not Applicable 3 3
Reaction 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2
Respiratory Distress 2 2
Sepsis 2 2
Dyspnea 2 2
Hematoma 2 2
Exposure to Body Fluids 2 2
Pulmonary Embolism 2 2
Abscess 1 1
Adult Respiratory Distress Syndrome 1 1
Air Embolism 1 1
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Transient Ischemic Attack 1 1
Venipuncture 1 1
Dizziness 1 1
Brain Injury 1 1
Pneumonia 1 1
Hemothorax 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Renal Failure 1 1
Loss of consciousness 1 1
Chest Tightness/Pressure 1 1
No Patient involvement 1 1
Lead(s), Burn(s) From 1 1
Sudden Cardiac Death 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Injury 1 1
Impaired Healing 1 1
Extubate 1 1
Ruptured Aneurysm 1 1
Thrombosis/Thrombus 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Blister 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
-
-