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)
2021	2022	2023	2024	2025	2026
8	13	4	1	7	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	573	577
Device Sensing Problem	266	268
Restricted Flow rate	258	258
Patient-Device Incompatibility	164	164
Increase in Pressure	110	110
Pumping Stopped	104	104
Failure to Advance	83	83
Positioning Failure	75	75
Deformation Due to Compressive Stress	47	47
Improper Flow or Infusion	39	39
Failure to Sense	31	31
Malposition of Device	24	24
Patient Device Interaction Problem	21	21
Fluid/Blood Leak	18	18
Defective Device	17	17
Activation, Positioning or Separation Problem	16	16
Material Twisted/Bent	16	16
Positioning Problem	14	14
Application Program Problem	13	13
Failure to Pump	13	13
Material Split, Cut or Torn	12	12
Difficult to Advance	10	10
Difficult to Insert	10	10
Insufficient Flow or Under Infusion	10	10
Infusion or Flow Problem	9	9
Decrease in Pressure	8	8
Failure to Read Input Signal	7	7
Difficult to Remove	7	7
Difficult or Delayed Positioning	7	7
Pressure Problem	6	6
Detachment of Device or Device Component	6	6
Break	5	5
Failure to Deliver	5	5
Material Deformation	5	5
No Pressure	5	5
Fracture	4	4
Crack	4	4
Migration	4	4
Material Separation	4	4
Unintended Application Program Shut Down	3	3
Defective Component	3	3
Migration or Expulsion of Device	3	3
Use of Device Problem	2	2
Computer Operating System Problem	2	2
Difficult to Open or Close	2	2
Obstruction of Flow	1	1
Failure to Power Up	1	1
Backflow	1	1
Inaccurate Flow Rate	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	751	753
Hemorrhage/Bleeding	374	378
Hemolysis	194	195
Thrombosis/Thrombus	174	174
Cardiovascular Insufficiency	66	66
Thrombocytopenia	48	48
Renal Failure	41	41
Arrhythmia	34	34
Ischemia	34	35
Unspecified Vascular Problem	33	33
Tachycardia	31	31
Sepsis	27	27
Hematoma	25	25
Perforation of Vessels	22	22
Cardiac Arrest	22	22
Hematuria	21	21
Stroke/CVA	20	20
Ventricular Fibrillation	19	19
Insufficient Information	17	17
Atrial Fibrillation	12	12
Renal Impairment	11	12
Cardiac Perforation	9	9
Low Blood Pressure/ Hypotension	8	8
Vascular Dissection	8	8
Embolism/Embolus	7	7
Multiple Organ Failure	7	7
Fever	7	7
Unspecified Infection	6	6
Pericardial Effusion	6	6
Pulmonary Edema	6	6
Bradycardia	6	6
Great Vessel Perforation	5	5
Asystole	5	5
Hypovolemia	4	4
Ischemia Stroke	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Cardiogenic Shock	3	3
Perforation	3	3
Inflammation	3	3
Respiratory Failure	3	3
Cardiac Tamponade	2	2
Heart Failure/Congestive Heart Failure	2	2
Anemia	2	2
Exsanguination	2	2
Gastrointestinal Hemorrhage	2	2
Pulmonary Valve Insufficiency/ Regurgitation	2	2
Hemothorax	2	2
Air Embolism	2	2
Foreign Body In Patient	1	1
Hemolytic Anemia	1	1