TPLC - Total Product Life Cycle

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Device	temporary non-roller type right heart support blood pump
Definition	Providing temporary partial or full right heart circulatory support.
Product Code	PYX
Regulation Number	870.4360
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
10	8	8	13	4	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	125	125
Improper Flow or Infusion	39	39
Pumping Stopped	35	35
Restricted Flow rate	21	21
Patient-Device Incompatibility	18	18
Activation, Positioning or Separation Problem	16	16
Material Twisted/Bent	12	12
Positioning Problem	10	10
Increase in Pressure	10	10
Insufficient Flow or Under Infusion	10	10
Positioning Failure	8	8
Device Sensing Problem	7	7
Difficult to Advance	7	7
Failure to Advance	6	6
Break	6	6
Insufficient Information	6	6
Material Split, Cut or Torn	6	6
Pressure Problem	5	5
Difficult to Insert	5	5
Material Deformation	5	5
Failure to Deliver	4	4
Deformation Due to Compressive Stress	4	4
Material Separation	4	4
Migration	4	4
Physical Resistance/Sticking	3	3
Crack	3	3
Difficult or Delayed Positioning	3	3
Infusion or Flow Problem	3	3
Detachment of Device or Device Component	2	2
Defective Device	2	2
Fluid/Blood Leak	2	2
Fracture	1	1
Material Fragmentation	1	1
Material Frayed	1	1
Mechanical Problem	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Suction Problem	1	1
Defective Component	1	1
Failure to Pump	1	1
Unable to Obtain Readings	1	1
Difficult to Remove	1	1
Inaccurate Delivery	1	1
Connection Problem	1	1
Power Problem	1	1
Unexpected Shutdown	1	1
Priming Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	164	164
Hemolysis	60	60
Hemorrhage/Bleeding	50	50
Thrombosis/Thrombus	30	30
Ischemia	10	10
Thrombocytopenia	9	9
Renal Failure	6	6
Perforation of Vessels	6	6
Device Embedded In Tissue or Plaque	6	6
Hematuria	5	5
Blood Loss	5	5
Stroke/CVA	5	5
Arrhythmia	4	4
Sepsis	4	4
Ventricular Fibrillation	4	4
Tachycardia	3	3
Vascular Dissection	3	3
Ischemia Stroke	3	3
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Renal Impairment	2	2
Cardiovascular Insufficiency	2	2
Insufficient Information	2	2
Hematoma	2	2
Bradycardia	2	2
Cardiac Arrest	2	2
Cardiac Perforation	2	2
Perforation	2	2
Cardiac Tamponade	2	2
Cardiogenic Shock	2	2
Obstruction/Occlusion	1	1
Respiratory Failure	1	1
Pulmonary Edema	1	1
Great Vessel Perforation	1	1
Pericardial Effusion	1	1
Abdominal Distention	1	1
Hypervolemia	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
No Known Impact Or Consequence To Patient	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Exsanguination	1	1
Hemothorax	1	1
Unspecified Infection	1	1
Air Embolism	1	1
Liver Damage/Dysfunction	1	1
Thrombus	1	1
Venipuncture	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pulmonary Valve Insufficiency/ Regurgitation	1	1
Lactate Dehydrogenase Increased	1	1
Asystole	1	1