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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
CARDIACASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 176 176
2019 310 310
2020 438 438
2021 447 447
2022 294 294
2023 243 243

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 275 275
Noise, Audible 223 223
Insufficient Information 180 180
Adverse Event Without Identified Device or Use Problem 165 165
Pumping Stopped 158 158
Mechanical Problem 134 134
Device Displays Incorrect Message 122 122
Infusion or Flow Problem 107 107
Overheating of Device 98 98
Battery Problem 69 69
Unexpected Shutdown 65 65
Communication or Transmission Problem 45 45
Pumping Problem 35 35
Decreased Pump Speed 29 29
Inaccurate Flow Rate 29 29
No Flow 25 25
Insufficient Flow or Under Infusion 22 22
Fluid/Blood Leak 21 21
Break 20 20
No Display/Image 19 19
Material Twisted/Bent 18 18
Excessive Heating 15 15
Increased Pump Speed 15 15
Display or Visual Feedback Problem 14 14
Disconnection 14 14
Leak/Splash 14 14
Crack 14 14
No Apparent Adverse Event 12 12
Power Problem 11 11
Obstruction of Flow 11 11
Use of Device Problem 11 11
Vibration 11 11
Failure to Pump 10 10
Device Difficult to Setup or Prepare 10 10
Electrical Power Problem 10 10
Connection Problem 9 9
Premature Discharge of Battery 8 8
Loose or Intermittent Connection 7 7
Loss of Power 7 7
Failure to Power Up 7 7
Device Stops Intermittently 7 7
Detachment of Device or Device Component 7 7
Charging Problem 7 7
Improper Flow or Infusion 6 6
Temperature Problem 6 6
Unexpected Therapeutic Results 6 6
Fitting Problem 6 6
Fracture 6 6
Device Alarm System 5 5
Erratic or Intermittent Display 5 5
Nonstandard Device 5 5
Material Deformation 5 5
Pressure Problem 4 4
Appropriate Term/Code Not Available 4 4
Material Puncture/Hole 4 4
Decoupling 4 4
Labelling, Instructions for Use or Training Problem 4 4
Image Display Error/Artifact 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Failure to Read Input Signal 3 3
Visual Prompts will not Clear 3 3
Defective Component 3 3
Misassembly by Users 3 3
Physical Resistance/Sticking 3 3
Protective Measures Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Visual Prompts/Feedback 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Electrical Shorting 3 3
Device Sensing Problem 3 3
Gas/Air Leak 3 3
Failure to Deliver 3 3
Inaccurate Delivery 3 3
High Readings 2 2
Failure to Align 2 2
Contamination /Decontamination Problem 2 2
Device Operates Differently Than Expected 2 2
Smoking 2 2
Failure to Shut Off 2 2
Material Integrity Problem 2 2
Complete Loss of Power 2 2
Unable to Obtain Readings 2 2
Particulates 2 2
Gradient Increase 2 2
Coagulation in Device or Device Ingredient 2 2
No Audible Alarm 2 2
Alarm Not Visible 2 2
False Alarm 1 1
Low Audible Alarm 1 1
Burst Container or Vessel 1 1
Failure to Charge 1 1
Clumping in Device or Device Ingredient 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Partial Blockage 1 1
Air Leak 1 1
Failure to Cycle 1 1
Display Difficult to Read 1 1
Difficult to Insert 1 1
Restricted Flow rate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 797 797
No Consequences Or Impact To Patient 303 303
No Patient Involvement 274 274
No Known Impact Or Consequence To Patient 231 231
Insufficient Information 88 88
Hemorrhage/Bleeding 55 55
Death 48 48
Thrombosis/Thrombus 30 30
Hemolysis 29 29
Thrombus 26 26
Cardiac Arrest 26 26
No Information 24 24
Heart Failure/Congestive Heart Failure 20 20
Low Oxygen Saturation 19 19
Blood Loss 16 16
Arrhythmia 16 16
Bacterial Infection 15 15
Thromboembolism 15 15
Renal Failure 14 14
Unspecified Infection 11 11
Stroke/CVA 11 11
Low Blood Pressure/ Hypotension 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Atrial Fibrillation 10 10
Cardiogenic Shock 10 10
Tachycardia 9 9
Sepsis 8 8
Hypoxia 8 8
Renal Impairment 8 8
Respiratory Failure 8 8
Ischemia Stroke 8 8
Thrombosis 7 7
Anemia 6 6
Hematoma 6 6
Multiple Organ Failure 6 6
Air Embolism 5 5
Complaint, Ill-Defined 5 5
Fungal Infection 5 5
Reaction 4 4
Right Ventricular Failure 4 4
Dyspnea 4 4
Bradycardia 4 4
Hematuria 4 4
Respiratory Insufficiency 4 4
Gastrointestinal Hemorrhage 4 4
Lactate Dehydrogenase Increased 3 3
Hemorrhagic Stroke 3 3
Ischemia 3 3
Ventricular Fibrillation 3 3
Hypovolemia 3 3
Obstruction/Occlusion 3 3
Injury 2 2
Brain Injury 2 2
Cardiac Tamponade 2 2
Septic Shock 2 2
Shock 2 2
Pleural Effusion 2 2
Liver Damage/Dysfunction 2 2
Neurological Deficit/Dysfunction 2 2
Pain 2 2
Intracranial Hemorrhage 2 2
Hemothorax 2 2
High Blood Pressure/ Hypertension 2 2
Cardiopulmonary Arrest 2 2
Infarction, Cerebral 2 2
Coagulation Disorder 2 2
Encephalopathy 2 2
Thrombocytopenia 2 2
Hydrocephalus 2 2
Aspiration Pneumonitis 2 2
Epistaxis 2 2
No Code Available 2 2
Not Applicable 2 2
Melena 2 2
Unspecified Gastrointestinal Problem 2 2
Liver Failure 2 2
Drug Resistant Bacterial Infection 1 1
Pancreatitis 1 1
Swelling/ Edema 1 1
Hypervolemia 1 1
Patient Problem/Medical Problem 1 1
Low Cardiac Output 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Abdominal Distention 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Respiratory Arrest 1 1
Cough 1 1
Valvular Insufficiency/ Regurgitation 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Cerebral Edema 1 1
Convulsion/Seizure 1 1
Embolism/Embolus 1 1
Exsanguination 1 1
Fever 1 1
Emotional Changes 1 1
Aneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc II Aug-25-2023
2 Cardiac Assist, Inc II May-11-2020
3 Maquet Cardiovascular Us Sales, Llc III Sep-12-2020
4 Maquet Cardiovascular Us Sales, Llc II Dec-12-2019
5 OriGen Biomedical, Inc. II Oct-30-2020
6 QURA S.R.L. II Aug-12-2021
7 Thoratec Switzerland GMBH I Oct-30-2019
8 Thoratec Switzerland GMBH II Oct-12-2018
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