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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 4
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 310 310
2020 438 438
2021 447 447
2022 294 294
2023 354 354
2024 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 344 344
Insufficient Information 229 229
Adverse Event Without Identified Device or Use Problem 187 187
Noise, Audible 176 176
Pumping Stopped 173 173
Infusion or Flow Problem 121 121
Device Displays Incorrect Message 119 119
Mechanical Problem 114 114
Overheating of Device 88 88
Battery Problem 75 75
Unexpected Shutdown 74 74
Communication or Transmission Problem 47 47
Pumping Problem 37 37
Inaccurate Flow Rate 34 34
No Flow 26 26
Decreased Pump Speed 25 25
Insufficient Flow or Under Infusion 22 22
Fluid/Blood Leak 21 21
No Display/Image 17 17
Increased Pump Speed 17 17
No Apparent Adverse Event 17 17
Excessive Heating 16 16
Material Twisted/Bent 16 16
Break 16 16
Disconnection 14 14
Display or Visual Feedback Problem 14 14
Device Difficult to Setup or Prepare 13 13
Obstruction of Flow 12 12
Electrical Power Problem 12 12
Use of Device Problem 11 11
Leak/Splash 11 11
Crack 10 10
Failure to Pump 10 10
Power Problem 10 10
Failure to Power Up 9 9
Premature Discharge of Battery 8 8
Loose or Intermittent Connection 7 7
Vibration 7 7
Product Quality Problem 7 7
Connection Problem 7 7
Detachment of Device or Device Component 7 7
Improper Flow or Infusion 6 6
Material Deformation 6 6
Loss of Power 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
Temperature Problem 5 5
Charging Problem 5 5
Device Sensing Problem 4 4
Gas/Air Leak 4 4
Pressure Problem 4 4
Appropriate Term/Code Not Available 4 4
Labelling, Instructions for Use or Training Problem 4 4
Material Puncture/Hole 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Failure to Read Input Signal 3 3
Image Display Error/Artifact 3 3
Defective Component 3 3
Failure to Deliver 3 3
Inaccurate Delivery 3 3
Decoupling 3 3
Physical Resistance/Sticking 3 3
No Visual Prompts/Feedback 3 3
Protective Measures Problem 3 3
Misassembly by Users 3 3
Therapeutic or Diagnostic Output Failure 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Electrical Shorting 3 3
Failure to Shut Off 2 2
Filtration Problem 2 2
Contamination /Decontamination Problem 2 2
Material Integrity Problem 2 2
Air/Gas in Device 2 2
Complete Loss of Power 2 2
Coagulation in Device or Device Ingredient 2 2
No Audible Alarm 2 2
Alarm Not Visible 2 2
Backflow 2 2
Partial Blockage 2 2
Particulates 2 2
Failure to Run on Battery 2 2
Nonstandard Device 2 2
Gradient Increase 2 2
High Readings 2 2
Failure to Align 2 2
Visual Prompts will not Clear 2 2
Unable to Obtain Readings 2 2
Failure to Select Signal 1 1
Smoking 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Decrease in Pressure 1 1
Failure to Prime 1 1
Off-Label Use 1 1
No Audible Prompt/Feedback 1 1
Device Damaged Prior to Use 1 1
Failure to Zero 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1003 1003
No Consequences Or Impact To Patient 281 281
No Patient Involvement 205 205
No Known Impact Or Consequence To Patient 175 175
Insufficient Information 96 96
Hemorrhage/Bleeding 63 63
Thrombosis/Thrombus 43 43
Death 42 42
Hemolysis 35 35
Cardiac Arrest 31 31
Heart Failure/Congestive Heart Failure 28 28
No Information 22 22
Thrombus 21 21
Low Oxygen Saturation 19 19
Renal Failure 17 17
Bacterial Infection 17 17
Arrhythmia 17 17
Thromboembolism 14 14
Multiple Organ Failure 14 14
Ischemia Stroke 13 13
Blood Loss 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Respiratory Failure 11 11
Stroke/CVA 11 11
Hypoxia 11 11
Unspecified Infection 11 11
Low Blood Pressure/ Hypotension 10 10
Atrial Fibrillation 10 10
Tachycardia 10 10
Cardiogenic Shock 10 10
Sepsis 8 8
Renal Impairment 8 8
Hematoma 7 7
Anemia 6 6
Intracranial Hemorrhage 6 6
Fungal Infection 5 5
Gastrointestinal Hemorrhage 5 5
Hemorrhagic Stroke 5 5
Hematuria 4 4
Respiratory Insufficiency 4 4
Lactate Dehydrogenase Increased 4 4
Reaction 4 4
Brain Injury 4 4
Right Ventricular Failure 4 4
Ventricular Fibrillation 4 4
Ischemia 4 4
Air Embolism 4 4
Bradycardia 4 4
Dyspnea 4 4
Encephalopathy 3 3
Liver Damage/Dysfunction 3 3
Hemothorax 3 3
High Blood Pressure/ Hypertension 3 3
Thrombosis 3 3
Septic Shock 3 3
Shock 3 3
Pain 3 3
Hypovolemia 3 3
Liver Failure 3 3
Obstruction/Occlusion 3 3
No Code Available 2 2
Convulsion/Seizure 2 2
Hydrocephalus 2 2
Thrombocytopenia 2 2
Aspiration Pneumonitis 2 2
Epistaxis 2 2
Kidney Infection 2 2
Drug Resistant Bacterial Infection 2 2
Unspecified Gastrointestinal Problem 2 2
Melena 2 2
Cardiac Tamponade 2 2
Complaint, Ill-Defined 2 2
Pleural Effusion 2 2
Visual Impairment 2 2
Muscle Weakness 2 2
Coagulation Disorder 2 2
Cardiopulmonary Arrest 2 2
Atrial Flutter 1 1
Exsanguination 1 1
Fever 1 1
Emotional Changes 1 1
Infarction, Cerebral 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Memory Loss/Impairment 1 1
Inflammation 1 1
Failure of Implant 1 1
Hyperthermia 1 1
Hemorrhage, Cerebral 1 1
Loss of Vision 1 1
Vomiting 1 1
Heart Failure 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Paralysis 1 1
Perforation 1 1
Respiratory Distress 1 1
Injury 1 1
Respiratory Tract Infection 1 1
Irritability 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 Maquet Medical Systems USA II Feb-02-2024
6 OriGen Biomedical, Inc. II Oct-30-2020
7 QURA S.R.L. II Aug-12-2021
8 Thoratec Switzerland GMBH I Oct-30-2019
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