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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 294 294

Device Problems MDRs with this Device Problem Events in those MDRs
Noise, Audible 234 234
Electrical /Electronic Property Problem 199 199
Pumping Stopped 142 142
Insufficient Information 140 140
Adverse Event Without Identified Device or Use Problem 132 132
Device Displays Incorrect Message 129 129
Mechanical Problem 123 123
Infusion or Flow Problem 98 98
Overheating of Device 96 96
Battery Problem 70 70
Unexpected Shutdown 56 56
Communication or Transmission Problem 43 43
Pumping Problem 33 33
Decreased Pump Speed 29 29
No Display/Image 29 29
No Flow 27 27
Inaccurate Flow Rate 22 22
Fluid/Blood Leak 21 21
Insufficient Flow or Under Infusion 21 21
Leak/Splash 20 20
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
Disconnection 13 13
Device Stops Intermittently 12 12
Increased Pump Speed 12 12
Failure to Pump 11 11
Use of Device Problem 11 11
Vibration 11 11
Connection Problem 10 10
Electrical Power Problem 9 9
Charging Problem 9 9
No Apparent Adverse Event 8 8
Improper Flow or Infusion 8 8
Device Difficult to Setup or Prepare 8 8
Loss of Power 8 8
Premature Discharge of Battery 8 8
Fracture 7 7
Loose or Intermittent Connection 7 7
Obstruction of Flow 7 7
Detachment of Device or Device Component 7 7
Device Operates Differently Than Expected 7 7
Temperature Problem 6 6
Device Alarm System 6 6
Failure to Power Up 6 6
Fitting Problem 6 6
Nonstandard Device 5 5
Decoupling 5 5
Erratic or Intermittent Display 5 5
Device Operational Issue 4 4
Pressure Problem 4 4
Material Deformation 4 4
Appropriate Term/Code Not Available 4 4
Labelling, Instructions for Use or Training Problem 4 4
Unexpected Therapeutic Results 4 4
Visual Prompts will not Clear 3 3
Unable to Obtain Readings 3 3
Failure to Read Input Signal 3 3
Air Leak 3 3
No Audible Alarm 3 3
Physical Resistance/Sticking 3 3
No Visual Prompts/Feedback 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Protective Measures Problem 3 3
Misassembly by Users 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Gas/Air Leak 3 3
Defective Component 3 3
Failure to Deliver 3 3
Inaccurate Delivery 3 3
Contamination /Decontamination Problem 2 2
Device Damaged Prior to Use 2 2
High Readings 2 2
Failure to Align 2 2
Device Contamination with Chemical or Other Material 2 2
Complete Loss of Power 2 2
Alarm Not Visible 2 2
False Alarm 2 2
Coagulation in Device or Device Ingredient 2 2
Gradient Increase 2 2
Smoking 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Shipping Damage or Problem 2 2
Failure to Zero 2 2
Device Inoperable 1 1
No Audible Prompt/Feedback 1 1
Failure to Reset 1 1
Sticking 1 1
Failure to Select Signal 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
No Device Output 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 608 608
No Consequences Or Impact To Patient 327 327
No Patient Involvement 317 317
No Known Impact Or Consequence To Patient 255 255
Insufficient Information 77 77
Death 57 57
Hemorrhage/Bleeding 40 40
Thrombus 30 30
Cardiac Arrest 28 28
Hemolysis 25 25
No Information 25 25
Blood Loss 21 21
Thrombosis/Thrombus 19 19
Low Oxygen Saturation 18 18
Heart Failure/Congestive Heart Failure 14 14
Low Blood Pressure/ Hypotension 12 12
Unspecified Infection 11 11
Thromboembolism 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Cardiogenic Shock 10 10
Bacterial Infection 10 10
Arrhythmia 10 10
Atrial Fibrillation 9 9
Stroke/CVA 9 9
Renal Failure 9 9
Sepsis 8 8
Hypoxia 8 8
Thrombosis 7 7
Complaint, Ill-Defined 7 7
Tachycardia 6 6
Hematoma 6 6
Anemia 6 6
Renal Impairment 6 6
Multiple Organ Failure 6 6
Air Embolism 5 5
Injury 5 5
Respiratory Failure 5 5
Fungal Infection 4 4
Reaction 4 4
Right Ventricular Failure 4 4
Hematuria 4 4
Respiratory Insufficiency 4 4
Gastrointestinal Hemorrhage 3 3
Ventricular Tachycardia 3 3
Hypovolemia 3 3
Obstruction/Occlusion 3 3
Coagulation Disorder 3 3
Bradycardia 3 3
Cardiopulmonary Arrest 3 3
Intracranial Hemorrhage 3 3
Ischemia 3 3
Liver Damage/Dysfunction 2 2
Neurological Deficit/Dysfunction 2 2
Hemothorax 2 2
Hemorrhage, Cerebral 2 2
Infarction, Cerebral 2 2
Brain Injury 2 2
Ventricular Fibrillation 2 2
Septic Shock 2 2
Shock 2 2
Melena 2 2
Unspecified Gastrointestinal Problem 2 2
Not Applicable 2 2
Lactate Dehydrogenase Increased 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Thrombocytopenia 2 2
No Code Available 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
Drug Resistant Bacterial Infection 1 1
Asystole 1 1
Liver Failure 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Epistaxis 1 1
Respiratory Arrest 1 1
Respiratory Distress 1 1
Inflammation 1 1
Tricuspid Regurgitation 1 1
Vomiting 1 1
Heart Failure 1 1
Cardiac Tamponade 1 1
Hemolytic Anemia 1 1
Anxiety 1 1
Numbness 1 1
Collapse 1 1
Irritability 1 1
Low Cardiac Output 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Chest Pain 1 1
Emotional Changes 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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