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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, blood, cardiopulmonary bypass, non-roller type
Regulation Description Nonroller-type blood pump.
Product CodeKFM
Regulation Number 870.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIAC ASSIST DIV.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 299 299
2016 155 155
2017 121 121
2018 172 172
2019 310 310
2020 314 314

Device Problems MDRs with this Device Problem Events in those MDRs
Noise, Audible 281 281
Device Displays Incorrect Message 162 162
Pumping Stopped 120 120
Pumping Problem 86 86
Adverse Event Without Identified Device or Use Problem 78 78
Overheating of Device 73 73
Mechanical Problem 67 67
Battery Problem 59 59
Leak/Splash 54 54
Infusion or Flow Problem 48 48
Insufficient Information 39 39
No Display/Image 35 35
Device Operates Differently Than Expected 34 34
No Flow 29 29
Battery 29 29
Fluid Leak 28 28
Communication or Transmission Problem 26 26
Power Problem 26 26
Decreased Pump Speed 21 21
Device Stops Intermittently 20 20
Insufficient Flow or Under Infusion 19 19
Material Twisted/Bent 17 17
Crack 15 15
Loss of Power 15 15
Fuse 15 15
Unexpected Shutdown 13 13
Break 12 12
Disconnection 12 12
Vibration 11 11
Charging Problem 11 11
Device Operational Issue 11 11
Connection Problem 10 10
Device Alarm System 10 10
Use of Device Problem 9 9
Display or Visual Feedback Problem 9 9
Inaccurate Flow Rate 7 7
Electrical Power Problem 7 7
Excessive Heating 7 7
Failure to Power Up 6 6
Nonstandard Device 6 6
Failure to Charge 6 6
Pump 6 6
Temperature Problem 6 6
Air Leak 5 5
Fracture 5 5
Improper Flow or Infusion 5 5
Device Contamination with Chemical or Other Material 5 5
Fitting Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Electrical /Electronic Property Problem 5 5
Decoupling 5 5
Motor(s) 5 5
Alarm 4 4
Alarm Not Visible 4 4
Detachment Of Device Component 4 4
Defective Component 4 4
Failure to Pump 4 4
Device Issue 4 4
Labelling, Instructions for Use or Training Problem 4 4
Incorrect Measurement 4 4
Alarm, LED 4 4
Appropriate Term/Code Not Available 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
No Device Output 3 3
Obstruction of Flow 3 3
Smoking 3 3
Difficult to Remove 3 3
Device Sensing Problem 3 3
Erratic or Intermittent Display 3 3
Failure to Run on Battery 3 3
Unable to Obtain Readings 3 3
Device Damaged Prior to Use 3 3
LED (Light Emitting Diode) 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Loose or Intermittent Connection 2 2
Increase in Pressure 2 2
Failure to Zero 2 2
Electrical Shorting 2 2
Low Battery 2 2
Malposition of Device 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Material Separation 2 2
Increased Pump Speed 2 2
Failure to Prime 2 2
Visual Prompts will not Clear 2 2
Out-Of-Box Failure 2 2
Packaging Problem 2 2
Failure to Align 2 2
Particulates 2 2
Cable, Electrical 2 2
No Audible Alarm 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Battery Charger 1 1
Material Split, Cut or Torn 1 1
Bent 1 1
Failure To Run On AC/DC 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 442 442
No Known Impact Or Consequence To Patient 356 356
No Consequences Or Impact To Patient 317 317
Death 64 64
Blood Loss 59 59
Thrombus 36 36
No Information 35 35
Cardiac Arrest 13 13
Hemolysis 10 10
Low Blood Pressure/ Hypotension 10 10
Complaint, Ill-Defined 8 8
Thrombosis 7 7
Injury 6 6
Unspecified Infection 6 6
Stroke/CVA 5 5
Multiple Organ Failure 5 5
Low Oxygen Saturation 5 5
Low Cardiac Output 4 4
Air Embolism 4 4
Cardiopulmonary Arrest 4 4
Reaction 4 4
No Code Available 4 4
Cardiogenic Shock 3 3
Right Ventricular Failure 3 3
Coagulation Disorder 3 3
Ischemia 3 3
Ventricular Tachycardia 3 3
Neurological Deficit/Dysfunction 3 3
Renal Failure 3 3
Sepsis 2 2
Sudden Cardiac Death 2 2
Hemorrhage, Cerebral 2 2
Intracranial Hemorrhage 2 2
Bradycardia 2 2
Embolus 2 2
Hemorrhage/Bleeding 2 2
Infarction, Cerebral 2 2
Arrhythmia 2 2
Shock 2 2
Anxiety 2 2
Respiratory Distress 2 2
Not Applicable 2 2
Thromboembolism 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 1 1
Loss Of Pulse 1 1
Depression 1 1
Tricuspid Regurgitation 1 1
Heart Failure 1 1
Scar Tissue 1 1
Seizures 1 1
Liver Damage/Dysfunction 1 1
Pain 1 1
Paralysis 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Abnormal Blood Gases 1 1
Syncope 1 1
Chest Pain 1 1
Hypoglycemia 1 1
Hypoxia 1 1
Bone Fracture(s) 1 1
Aneurysm 1 1
Left Ventricular Failure 1 1
Memory Loss/Impairment 1 1
Impotence 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Emotional Changes 1 1
Exsanguination 1 1
Fatigue 1 1
Fever 1 1
Hematoma 1 1
Skin Tears 1 1
Cognitive Changes 1 1
Hematuria 1 1
Cardiac Tamponade 1 1
Collapse 1 1
Loss of consciousness 1 1
Vessel Or Plaque, Device Embedded In 1 1
Right Ventricular Hypertrophy 1 1
Rash 1 1
Pericardial Effusion 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc II May-11-2020
2 Maquet Cardiovascular Us Sales, Llc III Sep-12-2020
3 Maquet Cardiovascular Us Sales, Llc II Dec-12-2019
4 Maquet Cardiovascular Us Sales, Llc II Apr-12-2016
5 Terumo Cardiovascular Systems Corporation II Feb-22-2017
6 Thoratec Switzerland GMBH I Oct-30-2019
7 Thoratec Switzerland GMBH II Oct-12-2018
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