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	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11892	11894
Restricted Flow rate	1401	1401
Patient-Device Incompatibility	1384	1384
Pumping Stopped	1087	1087
Positioning Failure	915	915
Application Program Problem	706	706
Activation, Positioning or Separation Problem	601	601
Fluid/Blood Leak	591	591
Increase in Pressure	549	549
Failure to Advance	541	541
Improper Flow or Infusion	489	489
Battery Problem	460	460
Positioning Problem	409	409
Deformation Due to Compressive Stress	358	358
Failure to Read Input Signal	330	330
Device Sensing Problem	300	300
Material Twisted/Bent	259	259
Difficult to Insert	239	239
Difficult to Advance	218	218
Infusion or Flow Problem	201	201
Break	193	193
No Pressure	184	184
Failure to Deliver	144	144
Computer Operating System Problem	140	140
Malposition of Device	139	139
Defective Device	131	131
Difficult to Remove	130	130
Crack	128	128
Pressure Problem	121	121
Connection Problem	120	120
Material Split, Cut or Torn	117	117
Fracture	115	115
Failure to Pump	107	107
Failure to Sense	96	96
Detachment of Device or Device Component	93	93
Insufficient Flow or Under Infusion	68	68
Display or Visual Feedback Problem	67	67
Insufficient Information	64	64
Decrease in Pressure	61	61
Priming Problem	60	60
Failure to Prime	58	58
Activation Failure	55	55
Use of Device Problem	48	48
Material Deformation	45	45
Unintended Application Program Shut Down	42	42
Device Handling Problem	33	33
Material Puncture/Hole	33	33
Key or Button Unresponsive/not Working	31	31
Optical Problem	31	31
Separation Problem	30	30

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9370	9370
Hemorrhage/Bleeding	5228	5229
Ischemia	2720	2721
Hemolysis	2038	2038
Hematoma	1409	1409
Thrombosis/Thrombus	1224	1225
Tachycardia	653	653
Stroke/CVA	476	476
Vascular Dissection	435	436
Thrombocytopenia	430	430
Ventricular Fibrillation	387	387
Cardiovascular Insufficiency	371	371
Sepsis	365	365
Arrhythmia	297	297
Perforation of Vessels	280	280
Renal Failure	256	256
Cardiac Perforation	198	198
Ischemia Stroke	172	172
Unspecified Infection	155	155
Cardiac Arrest	140	140
Atrial Fibrillation	138	138
Blood Loss	118	118
Insufficient Information	100	100
Hematuria	94	94
Hemorrhagic Stroke	67	67
Unspecified Vascular Problem	53	53
Gastrointestinal Hemorrhage	47	47
Renal Impairment	47	47
Aortic Valve Insufficiency/ Regurgitation	45	45
Perforation	44	44
No Known Impact Or Consequence To Patient	42	42
Low Blood Pressure/ Hypotension	37	37
Hemostasis	37	37
Bradycardia	36	36
Air Embolism	35	35
Cardiac Tamponade	32	32
Embolism/Embolus	29	29
Great Vessel Perforation	24	24
Pericardial Effusion	22	22
Cardiogenic Shock	22	22
Mitral Valve Insufficiency/ Regurgitation	22	22
Thrombus	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Device Embedded In Tissue or Plaque	17	17
Respiratory Failure	17	17
Valvular Insufficiency/ Regurgitation	17	17
Death	17	17
Anemia	16	16
Bacterial Infection	15	15
Mitral Regurgitation	15	15