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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 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 334 334
Insufficient Information 226 226
Adverse Event Without Identified Device or Use Problem 182 182
Noise, Audible 174 174
Pumping Stopped 168 168
Infusion or Flow Problem 121 121
Device Displays Incorrect Message 119 119
Mechanical Problem 112 112
Overheating of Device 88 88
Battery Problem 74 74
Unexpected Shutdown 72 72
Communication or Transmission Problem 47 47
Pumping Problem 35 35
Inaccurate Flow Rate 33 33
No Flow 26 26
Decreased Pump Speed 25 25
Insufficient Flow or Under Infusion 22 22
Fluid/Blood Leak 21 21
Increased Pump Speed 17 17
No Apparent Adverse Event 17 17
No Display/Image 17 17
Material Twisted/Bent 16 16
Excessive Heating 16 16
Break 15 15
Display or Visual Feedback Problem 14 14
Disconnection 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
Connection Problem 7 7
Product Quality Problem 7 7
Vibration 7 7
Detachment of Device or Device Component 7 7
Loose or Intermittent Connection 7 7
Improper Flow or Infusion 6 6
Loss of Power 6 6
Fitting Problem 6 6
Unexpected Therapeutic Results 6 6
Fracture 6 6
Charging Problem 5 5
Material Deformation 5 5
Temperature Problem 5 5
Erratic or Intermittent Display 5 5
Device Alarm System 5 5
Labelling, Instructions for Use or Training Problem 4 4
Pressure Problem 4 4
Device Sensing Problem 4 4
Gas/Air Leak 4 4
Material Puncture/Hole 4 4
Appropriate Term/Code Not Available 4 4
Therapeutic or Diagnostic Output Failure 3 3
Failure to Deliver 3 3
Decoupling 3 3
Failure to Read Input Signal 3 3
Defective Component 3 3
No Visual Prompts/Feedback 3 3
Image Display Error/Artifact 3 3
Electrical Shorting 3 3
Physical Resistance/Sticking 3 3
Protective Measures Problem 3 3
Misassembly by Users 3 3
Inaccurate Delivery 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Unable to Obtain Readings 2 2
Complete Loss of Power 2 2
Failure to Shut Off 2 2
Failure to Align 2 2
Nonstandard Device 2 2
Partial Blockage 2 2
Alarm Not Visible 2 2
Air/Gas in Device 2 2
Material Integrity Problem 2 2
Visual Prompts will not Clear 2 2
Gradient Increase 2 2
No Audible Alarm 2 2
Particulates 2 2
High Readings 2 2
Contamination /Decontamination Problem 2 2
Backflow 2 2
Coagulation in Device or Device Ingredient 2 2
Intermittent Communication Failure 1 1
Failure to Run on Battery 1 1
Smoking 1 1
Material Split, Cut or Torn 1 1
Shipping Damage or Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Fire 1 1
Expiration Date Error 1 1
Failure to Prime 1 1
Failure to Cycle 1 1
Display Difficult to Read 1 1
False Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 983 983
No Consequences Or Impact To Patient 281 281
No Patient Involvement 205 205
No Known Impact Or Consequence To Patient 175 175
Insufficient Information 93 93
Hemorrhage/Bleeding 63 63
Death 42 42
Thrombosis/Thrombus 42 42
Hemolysis 35 35
Cardiac Arrest 31 31
Heart Failure/Congestive Heart Failure 25 25
No Information 22 22
Thrombus 21 21
Low Oxygen Saturation 19 19
Bacterial Infection 17 17
Arrhythmia 17 17
Renal Failure 16 16
Thromboembolism 14 14
Blood Loss 13 13
Ischemia Stroke 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Multiple Organ Failure 11 11
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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