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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
Product CodeKFM
Regulation Number 870.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIACASSIST INC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 121 121
2018 176 176
2019 310 310
2020 438 438
2021 447 447
2022 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Noise, Audible 233 233
Electrical /Electronic Property Problem 178 178
Pumping Stopped 135 135
Device Displays Incorrect Message 129 129
Adverse Event Without Identified Device or Use Problem 126 126
Mechanical Problem 120 120
Insufficient Information 119 119
Overheating of Device 95 95
Infusion or Flow Problem 91 91
Battery Problem 64 64
Unexpected Shutdown 49 49
Communication or Transmission Problem 43 43
Pumping Problem 33 33
Decreased Pump Speed 29 29
No Display/Image 28 28
No Flow 27 27
Inaccurate Flow Rate 21 21
Insufficient Flow or Under Infusion 20 20
Leak/Splash 19 19
Fluid Leak 19 19
Break 18 18
Material Twisted/Bent 18 18
Crack 16 16
Display or Visual Feedback Problem 14 14
Power Problem 14 14
Excessive Heating 14 14
Device Stops Intermittently 12 12
Use of Device Problem 11 11
Vibration 11 11
Failure to Pump 11 11
Disconnection 11 11
Increased Pump Speed 10 10
Connection Problem 10 10
Electrical Power Problem 9 9
Charging Problem 9 9
Loss of Power 8 8
Loose or Intermittent Connection 7 7
Device Difficult to Setup or Prepare 7 7
Fracture 7 7
Premature Discharge of Battery 7 7
Obstruction of Flow 7 7
Device Operates Differently Than Expected 7 7
Improper Flow or Infusion 7 7
No Apparent Adverse Event 7 7
Temperature Problem 6 6
Detachment of Device or Device Component 6 6
Device Alarm System 6 6
Fitting Problem 6 6
Failure to Power Up 5 5
Erratic or Intermittent Display 5 5
Decoupling 5 5
Nonstandard Device 5 5
Labelling, Instructions for Use or Training Problem 4 4
Device Operational Issue 4 4
Appropriate Term/Code Not Available 4 4
Therapeutic or Diagnostic Output Failure 3 3
Misassembly by Users 3 3
Protective Measures Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Material Integrity Problem 3 3
No Visual Prompts/Feedback 3 3
Physical Resistance/Sticking 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Defective Component 3 3
Failure to Deliver 3 3
Inaccurate Delivery 3 3
Air Leak 3 3
No Audible Alarm 3 3
Visual Prompts will not Clear 3 3
Unable to Obtain Readings 3 3
Failure to Read Input Signal 3 3
Smoking 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Shipping Damage or Problem 2 2
Failure to Zero 2 2
Alarm Not Visible 2 2
False Alarm 2 2
Coagulation in Device or Device Ingredient 2 2
Gradient Increase 2 2
Failure to Align 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Gas Leak 2 2
Device Damaged Prior to Use 2 2
Complete Loss of Power 2 2
Pressure Problem 2 2
Mechanics Altered 1 1
Device Handling Problem 1 1
Migration 1 1
Material Split, Cut or Torn 1 1
Intermittent Loss of Power 1 1
Device Fell 1 1
Intermittent Communication Failure 1 1
Air/Gas in Device 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Failure of Device to Self-Test 1 1
Failure to Shut Off 1 1
Filtration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 537 537
No Consequences Or Impact To Patient 327 327
No Patient Involvement 317 317
No Known Impact Or Consequence To Patient 255 255
Insufficient Information 72 72
Death 57 57
Hemorrhage/Bleeding 35 35
Thrombus 30 30
Cardiac Arrest 28 28
No Information 25 25
Hemolysis 23 23
Blood Loss 21 21
Thrombosis/Thrombus 19 19
Low Oxygen Saturation 16 16
Heart Failure/Congestive Heart Failure 13 13
Low Blood Pressure/ Hypotension 12 12
Unspecified Infection 11 11
Cardiogenic Shock 10 10
Thromboembolism 10 10
Renal Failure 9 9
Sepsis 8 8
Arrhythmia 8 8
Atrial Fibrillation 8 8
Bacterial Infection 8 8
Stroke/CVA 8 8
Thrombosis 7 7
Complaint, Ill-Defined 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Renal Impairment 6 6
Multiple Organ Failure 6 6
Anemia 6 6
Hypoxia 6 6
Hematoma 6 6
Injury 5 5
Respiratory Failure 5 5
Tachycardia 5 5
Right Ventricular Failure 4 4
Fungal Infection 4 4
Reaction 4 4
Air Embolism 4 4
Hematuria 4 4
Gastrointestinal Hemorrhage 3 3
Coagulation Disorder 3 3
Cardiopulmonary Arrest 3 3
Bradycardia 3 3
Intracranial Hemorrhage 3 3
Ischemia 3 3
Hypovolemia 3 3
Obstruction/Occlusion 3 3
Ventricular Tachycardia 3 3
Ventricular Fibrillation 2 2
Septic Shock 2 2
Shock 2 2
Brain Injury 2 2
Liver Damage/Dysfunction 2 2
Neurological Deficit/Dysfunction 2 2
Hemothorax 2 2
Hemorrhage, Cerebral 2 2
Infarction, Cerebral 2 2
Melena 2 2
Unspecified Gastrointestinal Problem 2 2
Not Applicable 2 2
Respiratory Insufficiency 2 2
Hemorrhagic Stroke 2 2
Thrombocytopenia 2 2
No Code Available 2 2
Lactate Dehydrogenase Increased 2 2
Device Embedded In Tissue or Plaque 1 1
Pericardial Effusion 1 1
Cerebral Edema 1 1
Loss Of Pulse 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Patient Problem/Medical Problem 1 1
Abdominal Distention 1 1
Asystole 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Epistaxis 1 1
Respiratory Arrest 1 1
Liver Failure 1 1
Drug Resistant Bacterial Infection 1 1
Chest Pain 1 1
Emotional Changes 1 1
Exsanguination 1 1
Fever 1 1
Aneurysm 1 1
Failure of Implant 1 1
Pain 1 1
Paralysis 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Memory Loss/Impairment 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Cardiac Tamponade 1 1
Hemolytic Anemia 1 1
Anxiety 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 OriGen Biomedical, Inc. II Oct-30-2020
5 QURA S.R.L. II Aug-12-2021
6 Terumo Cardiovascular Systems Corporation II Feb-22-2017
7 Thoratec Switzerland GMBH I Oct-30-2019
8 Thoratec Switzerland GMBH II Oct-12-2018
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