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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device artificial heart
Definition P030011
Product CodeLOZ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
5 8 5 0 2 6

MDR Year MDR Reports MDR Events
2018 569 569
2019 379 379
2020 264 264
2021 241 241
2022 152 152
2023 135 135

Device Problems MDRs with this Device Problem Events in those MDRs
Audible Prompt/Feedback Problem 506 506
Adverse Event Without Identified Device or Use Problem 469 469
Mechanical Problem 161 161
Battery Problem 152 152
Appropriate Term/Code Not Available 139 139
Electrical /Electronic Property Problem 120 120
Output Problem 92 92
No Apparent Adverse Event 83 83
Device Displays Incorrect Message 63 63
Noise, Audible 55 55
Display or Visual Feedback Problem 45 45
Material Integrity Problem 31 31
Failure to Charge 23 23
Image Display Error/Artifact 22 22
Device Operates Differently Than Expected 22 22
Material Puncture/Hole 21 21
Break 20 20
Power Problem 17 17
Insufficient Information 16 16
Charging Problem 15 15
Device Operational Issue 13 13
Connection Problem 9 9
Fracture 8 8
Premature Discharge of Battery 7 7
No Display/Image 7 7
Physical Property Issue 7 7
Device Emits Odor 6 6
Device Inoperable 6 6
Difficult to Insert 5 5
Crack 5 5
Material Discolored 5 5
Temperature Problem 5 5
Activation, Positioning or Separation Problem 5 5
Contamination /Decontamination Problem 4 4
Device Stops Intermittently 4 4
Disconnection 4 4
Filling Problem 4 4
Calibration Problem 4 4
Failure to Calibrate 3 3
Incorrect Or Inadequate Test Results 3 3
Loose or Intermittent Connection 3 3
Material Too Rigid or Stiff 3 3
Sticking 3 3
Restricted Flow rate 3 3
Detachment Of Device Component 3 3
Air Leak 3 3
Material Deformation 3 3
Physical Resistance/Sticking 3 3
No Visual Prompts/Feedback 2 2
Material Split, Cut or Torn 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure of Device to Self-Test 2 2
Computer Operating System Problem 2 2
Device Sensing Problem 2 2
Pressure Problem 2 2
Mechanical Jam 2 2
No Audible Alarm 2 2
Computer Software Problem 2 2
Display Difficult to Read 2 2
Degraded 2 2
Leak/Splash 2 2
Difficult to Remove 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Overfill 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Obstruction of Flow 1 1
Device Issue 1 1
Unstable 1 1
Split 1 1
Low Battery 1 1
Defective Device 1 1
Visual Prompts will not Clear 1 1
No Audible Prompt/Feedback 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Aborted Charge 1 1
Defective Component 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Short Fill 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Incorrect Measurement 1 1
Product Quality Problem 1 1
Radiation Leak 1 1
Inflation Problem 1 1
Overheating of Device 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Failure to Pump 1 1
Pumping Stopped 1 1
Material Frayed 1 1
Material Erosion 1 1
Thermal Decomposition of Device 1 1
Calibration Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 540 540
No Consequences Or Impact To Patient 427 427
No Patient Involvement 315 315
Death 207 207
Bacterial Infection 132 132
Respiratory Failure 126 126
No Known Impact Or Consequence To Patient 109 109
Hemorrhage/Bleeding 105 105
Renal Failure 101 101
Multiple Organ Failure 98 98
Neurological Deficit/Dysfunction 86 86
Patient Problem/Medical Problem 44 44
Hemolysis 38 38
Liver Damage/Dysfunction 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Loss of consciousness 31 31
Sepsis 30 30
Stroke/CVA 30 30
Fungal Infection 27 27
Renal Impairment 24 24
Urinary Tract Infection 21 21
Unspecified Infection 19 19
No Code Available 18 18
Thromboembolism 15 15
Viral Infection 11 11
Thrombosis/Thrombus 11 11
No Information 10 10
High Blood Pressure/ Hypertension 9 9
Hemorrhage, Cerebral 6 6
Insufficient Information 6 6
Pericardial Effusion 5 5
Cardiomyopathy 5 5
Wound Dehiscence 5 5
Encephalopathy 5 5
Hypervolemia 5 5
Pulmonary Edema 4 4
Convulsion/Seizure 4 4
Hemorrhagic Stroke 3 3
Liver Failure 3 3
Ischemia 3 3
Intracranial Hemorrhage 3 3
Pulmonary Embolism 3 3
Bowel Perforation 3 3
Low Cardiac Output 3 3
Lethargy 2 2
Decreased Respiratory Rate 2 2
Coma 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Dizziness 2 2
Brain Injury 2 2
Right Ventricular Failure 2 2
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Pulmonary Dysfunction 2 2
Unspecified Hepatic or Biliary Problem 2 2
Heart Failure/Congestive Heart Failure 2 2
Unspecified Nervous System Problem 2 2
Suicidal Ideation 2 2
Arteriosclerosis/ Atherosclerosis 1 1
Embolism/Embolus 1 1
Skin Inflammation/ Irritation 1 1
Inflammation 1 1
Liver Laceration(s) 1 1
Hypoxia 1 1
Failure of Implant 1 1
Abdominal Pain 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Cardiopulmonary Arrest 1 1
Congenital Defect/Deformity 1 1
Congestive Heart Failure 1 1
Fainting 1 1
Fall 1 1
Headache 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Edema 1 1
Embolus 1 1
Seizures 1 1
Blurred Vision 1 1
Septic Shock 1 1
Shock 1 2
Thrombosis 1 1
Thrombus 1 1
Transient Ischemic Attack 1 1
Heart Failure 1 1
Depression 1 1
Cardiogenic Shock 1 1
Anxiety 1 1
Test Result 1 1
Obstruction/Occlusion 1 1
Palpitations 1 1

Recalls
Manufacturer Recall Class Date Posted
1 SynCardia Systems LLC II Oct-20-2023
2 SynCardia Systems LLC II Jan-27-2023
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