TPLC - Total Product Life Cycle

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Device	temporary non-roller type left heart support blood pump
Definition	A blood pump that provides temporary full or partial left heart support
Product Code	OZD
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
19	12	13	15	8	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9784	9786
Restricted Flow rate	854	854
Patient-Device Incompatibility	785	785
Pumping Stopped	631	631
Activation, Positioning or Separation Problem	601	601
Positioning Failure	563	563
Improper Flow or Infusion	487	487
Fluid/Blood Leak	438	438
Positioning Problem	403	403
Increase in Pressure	317	317
Failure to Advance	267	267
Material Twisted/Bent	230	230
Difficult to Advance	215	215
Application Program Problem	214	214
Difficult to Insert	189	189
Break	166	166
Battery Problem	153	153
Device Sensing Problem	144	144
Failure to Deliver	144	144
Computer Operating System Problem	140	140
Infusion or Flow Problem	134	134
Malposition of Device	118	118
Pressure Problem	118	118
Deformation Due to Compressive Stress	111	111
Difficult to Remove	98	98
Crack	98	98
Connection Problem	94	94
Material Split, Cut or Torn	75	75
Fracture	73	73
Insufficient Flow or Under Infusion	68	68
Insufficient Information	64	64
Detachment of Device or Device Component	60	60
Activation Failure	55	55
Failure to Read Input Signal	49	49
Material Deformation	45	45
Failure to Pump	41	41
Defective Device	40	40
Failure to Sense	38	38
No Pressure	37	37
Use of Device Problem	36	36
Device Handling Problem	32	32
Optical Problem	31	31
Material Separation	30	30
Separation Problem	30	30
Display or Visual Feedback Problem	26	26
Material Puncture/Hole	26	26
Activation Problem	26	26
Priming Problem	26	26
Device Alarm System	25	25
Failure to Prime	23	23

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5710	5710
Hemorrhage/Bleeding	4208	4209
Ischemia	2374	2375
Hemolysis	1592	1592
Hematoma	1185	1185
Thrombosis/Thrombus	918	919
Tachycardia	513	513
Vascular Dissection	383	384
Ventricular Fibrillation	316	316
Stroke/CVA	311	311
Thrombocytopenia	310	310
Sepsis	272	272
Perforation of Vessels	232	232
Arrhythmia	193	193
Renal Failure	174	174
Cardiac Perforation	171	171
Ischemia Stroke	155	155
Unspecified Infection	120	120
Blood Loss	118	118
Atrial Fibrillation	105	105
Cardiac Arrest	90	90
Hematuria	70	70
Cardiovascular Insufficiency	57	57
Insufficient Information	55	55
Hemorrhagic Stroke	45	45
No Known Impact Or Consequence To Patient	42	42
Renal Impairment	41	41
Aortic Valve Insufficiency/ Regurgitation	39	39
Unspecified Vascular Problem	38	38
Perforation	38	38
Hemostasis	37	37
Gastrointestinal Hemorrhage	31	31
Air Embolism	30	30
Low Blood Pressure/ Hypotension	29	29
Cardiac Tamponade	26	26
Bradycardia	25	25
Thrombus	20	20
Great Vessel Perforation	19	19
Mitral Valve Insufficiency/ Regurgitation	18	18
Death	17	17
Embolism/Embolus	16	16
Device Embedded In Tissue or Plaque	16	16
Mitral Regurgitation	15	15
Pericardial Effusion	15	15
Cardiogenic Shock	14	14
Anemia	14	14
Retroperitoneal Hemorrhage	13	13
Valvular Insufficiency/ Regurgitation	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Aortic Regurgitation	12	12