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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	0	0	5	8	12	17	19	12	13	15	8	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9851	9853
Restricted Flow rate	855	855
Patient-Device Incompatibility	817	817
Pumping Stopped	635	635
Activation, Positioning or Separation Problem	606	606
Positioning Failure	563	563
Improper Flow or Infusion	487	487
Fluid/Blood Leak	440	440
Positioning Problem	424	424
Increase in Pressure	317	317
Failure to Advance	267	267
Material Twisted/Bent	231	231
Difficult to Advance	219	219
Application Program Problem	214	214
Difficult to Insert	195	195
Break	173	173
Battery Problem	153	153
Device Sensing Problem	144	144
Failure to Deliver	144	144
Computer Operating System Problem	140	140
Infusion or Flow Problem	137	137
Malposition of Device	137	137
Pressure Problem	119	119
Deformation Due to Compressive Stress	113	113
Difficult to Remove	112	112
Crack	101	101
Connection Problem	94	94
Fracture	79	79
Material Split, Cut or Torn	75	75
Insufficient Information	75	75
Insufficient Flow or Under Infusion	68	68
Detachment of Device or Device Component	62	62
Activation Failure	55	55
Failure to Read Input Signal	49	49
Material Deformation	49	49
Use of Device Problem	44	44
Failure to Pump	41	41
Device Handling Problem	40	40
Defective Device	40	40
Failure to Sense	38	38
Material Separation	38	38
No Pressure	37	37
Patient Device Interaction Problem	33	33
Optical Problem	31	31
Separation Problem	30	30
Difficult or Delayed Positioning	27	27
Material Puncture/Hole	26	26
Activation Problem	26	26
Human-Device Interface Problem	26	26
Priming Problem	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5710	5710
Hemorrhage/Bleeding	4213	4214
Ischemia	2405	2406
Hemolysis	1624	1624
Hematoma	1227	1227
Thrombosis/Thrombus	918	919
Tachycardia	513	513
Vascular Dissection	387	388
Ventricular Fibrillation	317	317
Stroke/CVA	312	312
Thrombocytopenia	310	310
Sepsis	272	272
Blood Loss	242	242
Perforation of Vessels	240	240
Arrhythmia	193	193
Cardiac Perforation	175	175
Renal Failure	175	175
Ischemia Stroke	155	155
Unspecified Infection	120	120
Atrial Fibrillation	105	105
Cardiac Arrest	91	91
Hematuria	72	72
Perforation	65	65
No Known Impact Or Consequence To Patient	61	61
Cardiovascular Insufficiency	57	57
Insufficient Information	55	55
Hemorrhagic Stroke	45	45
Low Blood Pressure/ Hypotension	44	44
Renal Impairment	41	41
Aortic Valve Insufficiency/ Regurgitation	39	39
Unspecified Vascular Problem	38	38
Hemostasis	37	37
Gastrointestinal Hemorrhage	31	31
Thrombus	31	31
Air Embolism	30	30
Bradycardia	28	28
Cardiac Tamponade	28	28
Death	24	24
Device Embedded In Tissue or Plaque	24	24
Mitral Regurgitation	23	23
Great Vessel Perforation	19	19
No Code Available	19	19
Mitral Valve Insufficiency/ Regurgitation	18	18
Patient Problem/Medical Problem	18	18
Embolism/Embolus	16	16
Pericardial Effusion	16	16
Cardiogenic Shock	15	15
Injury	15	15
Rupture	15	15
No Consequences Or Impact To Patient	14	14