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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	79	79
Improper Flow or Infusion	28	28
Pumping Stopped	27	27
Activation, Positioning or Separation Problem	13	13
Material Twisted/Bent	9	9
Patient-Device Incompatibility	8	8
Restricted Flow rate	8	8
Insufficient Flow or Under Infusion	7	7
Difficult to Advance	7	7
Break	6	6
Increase in Pressure	6	6
Insufficient Information	6	6
Material Split, Cut or Torn	5	5
Failure to Advance	5	5
Material Deformation	5	5
Positioning Problem	4	4
Deformation Due to Compressive Stress	4	4
Failure to Deliver	4	4
Migration	4	4
Physical Resistance/Sticking	3	3
Material Separation	3	3
Pressure Problem	3	3
Infusion or Flow Problem	3	3
Positioning Failure	2	2
Device Sensing Problem	2	2
Crack	2	2
Fluid/Blood Leak	2	2
Material Fragmentation	1	1
Difficult to Insert	1	1
Mechanical Problem	1	1
Failure to Power Up	1	1
Difficult or Delayed Positioning	1	1
Failure to Pump	1	1
Use of Device Problem	1	1
Suction Problem	1	1
Unable to Obtain Readings	1	1
Difficult to Remove	1	1
Inaccurate Delivery	1	1
Defective Component	1	1
Detachment of Device or Device Component	1	1
Connection Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Unexpected Shutdown	1	1
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	113	113
Hemolysis	40	40
Hemorrhage/Bleeding	26	26
Thrombosis/Thrombus	19	19
Device Embedded In Tissue or Plaque	6	6
Blood Loss	5	5
Perforation of Vessels	4	4
Hematuria	4	4
Ischemia	4	4
Thrombocytopenia	4	4
Perforation	2	2
Sepsis	2	2
Stroke/CVA	2	2
Vascular Dissection	2	2
Cardiac Tamponade	2	2
Obstruction/Occlusion	1	1
Cardiac Perforation	1	1
Abdominal Distention	1	1
Hypervolemia	1	1
Patient Problem/Medical Problem	1	1
No Known Impact Or Consequence To Patient	1	1
Pericardial Effusion	1	1
Cardiovascular Insufficiency	1	1
Pulmonary Valve Insufficiency/ Regurgitation	1	1
Lactate Dehydrogenase Increased	1	1
Insufficient Information	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Hematoma	1	1
Hemothorax	1	1
Air Embolism	1	1
Arrhythmia	1	1
Bradycardia	1	1
Cardiac Arrest	1	1
Tachycardia	1	1
Thrombus	1	1
Venipuncture	1	1
Ventricular Fibrillation	1	1
Renal Failure	1	1
Liver Damage/Dysfunction	1	1