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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
Material Twisted/Bent 18 18
Break 18 18
Crack 16 16
Display or Visual Feedback Problem 14 14
Power Problem 14 14
Excessive Heating 14 14
Disconnection 13 13
Increased Pump Speed 12 12
Device Stops Intermittently 12 12
Vibration 11 11
Failure to Pump 11 11
Use of Device Problem 11 11
Connection Problem 10 10
Electrical Power Problem 9 9
Charging Problem 9 9
Loss of Power 8 8
Premature Discharge of Battery 8 8
Improper Flow or Infusion 8 8
Device Difficult to Setup or Prepare 8 8
No Apparent Adverse Event 8 8
Detachment of Device or Device Component 7 7
Obstruction of Flow 7 7
Loose or Intermittent Connection 7 7
Device Operates Differently Than Expected 7 7
Fracture 7 7
Failure to Power Up 6 6
Fitting Problem 6 6
Device Alarm System 6 6
Temperature Problem 6 6
Nonstandard Device 5 5
Erratic or Intermittent Display 5 5
Decoupling 5 5
Unexpected Therapeutic Results 4 4
Pressure Problem 4 4
Material Deformation 4 4
Device Operational Issue 4 4
Labelling, Instructions for Use or Training Problem 4 4
Appropriate Term/Code Not Available 4 4
Therapeutic or Diagnostic Output Failure 3 3
No Audible Alarm 3 3
Failure to Deliver 3 3
Inaccurate Delivery 3 3
Unable to Obtain Readings 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Gas/Air Leak 3 3
Visual Prompts will not Clear 3 3
Air Leak 3 3
Protective Measures Problem 3 3
Misassembly by Users 3 3
Material Integrity Problem 3 3
Electrical Shorting 3 3
Defective Component 3 3
Device Sensing Problem 3 3
Failure to Read Input Signal 3 3
Physical Resistance/Sticking 3 3
No Visual Prompts/Feedback 3 3
Device Contamination with Chemical or Other Material 2 2
Failure to Zero 2 2
False Alarm 2 2
Alarm Not Visible 2 2
Contamination /Decontamination Problem 2 2
Complete Loss of Power 2 2
Device Damaged Prior to Use 2 2
High Readings 2 2
Coagulation in Device or Device Ingredient 2 2
Failure to Align 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Shipping Damage or Problem 2 2
Smoking 2 2
Gradient Increase 2 2
Failure to Charge 1 1
Collapse 1 1
Inadequate Instructions for Healthcare Professional 1 1
No Device Output 1 1
Particulates 1 1
Material Puncture/Hole 1 1
Calibration Problem 1 1
Device Dislodged or Dislocated 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 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 16 16
Heart Failure/Congestive Heart Failure 14 14
Low Blood Pressure/ Hypotension 12 12
Thromboembolism 11 11
Unspecified Infection 11 11
Cardiogenic Shock 10 10
Arrhythmia 10 10
Bacterial Infection 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Renal Failure 9 9
Stroke/CVA 9 9
Atrial Fibrillation 9 9
Sepsis 8 8
Hypoxia 8 8
Thrombosis 7 7
Complaint, Ill-Defined 7 7
Tachycardia 6 6
Anemia 6 6
Hematoma 6 6
Renal Impairment 6 6
Multiple Organ Failure 6 6
Respiratory Failure 5 5
Air Embolism 5 5
Injury 5 5
Reaction 4 4
Fungal Infection 4 4
Hematuria 4 4
Right Ventricular Failure 4 4
Respiratory Insufficiency 4 4
Gastrointestinal Hemorrhage 3 3
Obstruction/Occlusion 3 3
Bradycardia 3 3
Ventricular Tachycardia 3 3
Hypovolemia 3 3
Intracranial Hemorrhage 3 3
Ischemia 3 3
Cardiopulmonary Arrest 3 3
Coagulation Disorder 3 3
Hemothorax 2 2
Ventricular Fibrillation 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Lactate Dehydrogenase Increased 2 2
Melena 2 2
Unspecified Gastrointestinal Problem 2 2
Neurological Deficit/Dysfunction 2 2
Hemorrhage, Cerebral 2 2
Septic Shock 2 2
Thrombocytopenia 2 2
Infarction, Cerebral 2 2
Liver Damage/Dysfunction 2 2
Shock 2 2
Brain Injury 2 2
Not Applicable 2 2
No Code Available 2 2
Asystole 1 1
Respiratory Arrest 1 1
Liver Failure 1 1
Irritability 1 1
Patient Problem/Medical Problem 1 1
Heart Failure 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Pulmonary Edema 1 1
Epistaxis 1 1
Collapse 1 1
Atrial Flutter 1 1
Exsanguination 1 1
Inflammation 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Abdominal Distention 1 1
Pericardial Effusion 1 1
Emotional Changes 1 1
Fever 1 1
Failure of Implant 1 1
Memory Loss/Impairment 1 1
Aneurysm 1 1
Low Cardiac Output 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Cardiac Tamponade 1 1
Numbness 1 1
Device Embedded In Tissue or Plaque 1 1
Cerebral Edema 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Drug Resistant Bacterial Infection 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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