TPLC - Total Product Life Cycle

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Device	temporary non-roller type right heart support blood pump
Regulation Description	Nonroller-type 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)
2020	2021	2022	2023	2024	2025
8	8	13	4	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	449	449
Restricted Flow rate	160	160
Patient-Device Incompatibility	145	145
Pumping Stopped	84	85
Increase in Pressure	76	76
Positioning Failure	64	64
Failure to Advance	62	62
Deformation Due to Compressive Stress	40	40
Improper Flow or Infusion	39	39
Device Sensing Problem	20	20
Failure to Sense	19	19
Fluid/Blood Leak	16	16
Material Twisted/Bent	16	16
Activation, Positioning or Separation Problem	16	16
Defective Device	16	16
Positioning Problem	13	13
Insufficient Flow or Under Infusion	10	10
Difficult to Insert	10	10
Material Split, Cut or Torn	9	9
Malposition of Device	9	9
Failure to Pump	8	8
Difficult to Advance	8	8
Infusion or Flow Problem	7	7
Difficult or Delayed Positioning	7	7
Detachment of Device or Device Component	6	6
Break	6	6
Pressure Problem	5	5
Failure to Deliver	5	5
Application Program Problem	5	5
Failure to Read Input Signal	5	5
Difficult to Remove	5	5
Material Deformation	5	5
Insufficient Information	4	4
No Pressure	4	4
Migration	4	4
Crack	3	3
Migration or Expulsion of Device	3	3
Defective Component	3	3
Unintended Application Program Shut Down	3	3
Material Separation	2	2
Fracture	2	2
Connection Problem	1	1
Unintended Movement	1	1
Obstruction of Flow	1	1
Device Handling Problem	1	1
Priming Problem	1	1
Optical Problem	1	1
Use of Device Problem	1	1
Failure to Power Up	1	1
Unable to Obtain Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	521	522
Hemorrhage/Bleeding	295	295
Hemolysis	126	126
Thrombosis/Thrombus	115	115
Cardiovascular Insufficiency	61	61
Thrombocytopenia	38	38
Renal Failure	26	26
Ischemia	24	24
Perforation of Vessels	20	20
Hematoma	19	19
Sepsis	19	19
Tachycardia	18	18
Arrhythmia	14	14
Ventricular Fibrillation	14	14
Stroke/CVA	11	11
Cardiac Arrest	10	10
Insufficient Information	9	9
Vascular Dissection	8	8
Renal Impairment	8	8
Hematuria	7	7
Cardiac Perforation	6	6
Atrial Fibrillation	5	5
Great Vessel Perforation	5	5
Bradycardia	4	4
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Asystole	3	3
Ischemia Stroke	3	3
Pericardial Effusion	3	3
Cardiac Tamponade	2	2
Perforation	2	2
Hypovolemia	2	2
Cardiogenic Shock	2	2
Gastrointestinal Hemorrhage	2	2
Air Embolism	2	2
Unspecified Vascular Problem	2	2
Embolism/Embolus	2	2
Multiple Organ Failure	2	2
Device Embedded In Tissue or Plaque	2	2
Hemothorax	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemolytic Anemia	1	1
Obstruction/Occlusion	1	1
Respiratory Failure	1	1
Lactate Dehydrogenase Increased	1	1
Low Cardiac Output	1	1
Unspecified Infection	1	1
Exsanguination	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Venipuncture	1	1
Pulmonary Edema	1	1