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	2026
8	8	13	4	1	7	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	672	676
Device Sensing Problem	408	410
Restricted Flow rate	339	339
Patient-Device Incompatibility	165	165
Increase in Pressure	153	153
Pumping Stopped	119	120
Patient Device Interaction Problem	115	115
Failure to Advance	96	96
Positioning Failure	77	77
Malposition of Device	52	52
Deformation Due to Compressive Stress	52	52
Improper Flow or Infusion	39	39
Failure to Sense	31	31
Application Program Problem	25	25
Fluid/Blood Leak	21	21
Material Split, Cut or Torn	17	17
Defective Device	17	17
Material Twisted/Bent	16	16
Activation, Positioning or Separation Problem	16	16
Positioning Problem	15	15
Failure to Read Input Signal	15	15
Failure to Pump	14	14
Difficult to Insert	13	13
Decrease in Pressure	13	13
Difficult to Remove	11	11
Difficult or Delayed Positioning	11	11
Difficult to Advance	11	11
Insufficient Flow or Under Infusion	10	10
Break	9	9
Infusion or Flow Problem	9	9
Use of Device Problem	6	6
Crack	6	6
Detachment of Device or Device Component	6	6
Pressure Problem	6	6
Material Deformation	5	5
No Pressure	5	5
Failure to Deliver	5	5
Fracture	4	4
Material Separation	4	4
Computer Operating System Problem	4	4
Unintended Application Program Shut Down	4	4
Migration	4	4
Insufficient Device Problem Information	4	4
Migration or Expulsion of Device	3	3
Inaccurate Flow Rate	3	3
Display or Visual Feedback Problem	3	3
Device Damaged by Another Device	3	3
Difficult to Open or Close	3	3
Defective Component	3	3
Degraded	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	914	916
Hemorrhage/Blood Loss/Bleeding	453	457
Hemolysis	269	270
Thrombosis/Thrombus	203	203
Cardiovascular Dysfunction/Insufficiency	66	66
Hemodynamic instability	64	64
Thrombocytopenia	63	63
Renal Failure	62	62
Arrhythmia	43	43
Cardiac Arrest	40	40
Ischemia	36	37
Hematoma	35	35
Tachycardia	34	34
Hematuria	34	34
Unspecified Vascular Problem	33	33
Sepsis	31	31
Stroke/CVA	26	26
Perforation of Vessels	23	23
Ventricular Fibrillation	20	20
Insufficient Information	20	20
Anemia	15	15
Low Blood Pressure/ Hypotension	15	15
Atrial Fibrillation	15	15
Thromboembolism	13	13
Renal Impairment	12	13
Pericardial Effusion	12	12
Bradycardia	11	11
Multiple Organ Dysfunction Syndrome	11	11
Fever	10	10
Cardiac Perforation	10	10
Respiratory Failure	10	10
Vascular Dissection	9	9
Unspecified Infection	8	8
Pulmonary Edema	8	8
Embolism/Embolus	7	7
Cardiogenic Shock	6	6
Heart Failure/Congestive Heart Failure	6	6
Asystole	6	6
Great Vessel Perforation	5	5
Hemoptysis	5	5
Perforation	4	4
Ischemia Stroke	4	4
Hypovolemia	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Cardiac Tamponade	4	4
Inflammation	3	3
Exsanguination	2	2
Hemothorax	2	2
Device Embedded In Tissue or Plaque	2	2
Heart Block	2	2