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)
2020	2021	2022	2023	2024	2025
12	13	15	8	5	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	13349	13349
Restricted Flow rate	1790	1790
Patient-Device Incompatibility	1768	1768
Pumping Stopped	1287	1287
Positioning Failure	1255	1255
Application Program Problem	925	925
Failure to Advance	811	811
Increase in Pressure	745	745
Fluid/Blood Leak	697	697
Activation, Positioning or Separation Problem	600	600
Battery Problem	533	533
Deformation Due to Compressive Stress	509	509
Improper Flow or Infusion	489	489
Positioning Problem	433	433
Failure to Read Input Signal	412	412
Device Sensing Problem	409	409
Material Twisted/Bent	277	277
Difficult to Insert	265	265
Malposition of Device	255	255
Infusion or Flow Problem	253	253
No Pressure	223	223
Difficult to Advance	220	220
Defective Device	198	198
Break	192	192
Material Split, Cut or Torn	167	167
Crack	149	149
Difficult to Remove	146	146
Failure to Deliver	144	144
Computer Operating System Problem	140	140
Failure to Pump	134	134
Connection Problem	130	130
Detachment of Device or Device Component	127	127
Fracture	122	122
Pressure Problem	121	121
Failure to Sense	113	113
Display or Visual Feedback Problem	90	90
Decrease in Pressure	85	85
Priming Problem	84	84
Unintended Application Program Shut Down	68	68
Insufficient Flow or Under Infusion	68	68
Failure to Prime	61	61
Use of Device Problem	59	59
Activation Failure	55	55
Key or Button Unresponsive/not Working	45	45
Material Deformation	45	45
Material Puncture/Hole	38	38
Device Handling Problem	35	35
Material Separation	34	34
Migration or Expulsion of Device	33	33
Optical Problem	31	31

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11202	11202
Hemorrhage/Bleeding	6004	6004
Ischemia	3035	3035
Hemolysis	2301	2301
Hematoma	1640	1640
Thrombosis/Thrombus	1485	1485
Tachycardia	827	827
Stroke/CVA	589	589
Thrombocytopenia	507	507
Vascular Dissection	480	480
Arrhythmia	470	470
Ventricular Fibrillation	456	456
Cardiovascular Insufficiency	423	423
Sepsis	408	408
Perforation of Vessels	322	322
Renal Failure	298	298
Cardiac Perforation	217	217
Cardiac Arrest	205	205
Atrial Fibrillation	201	201
Ischemia Stroke	191	191
Unspecified Infection	175	175
Insufficient Information	150	150
Hematuria	105	105
Hemorrhagic Stroke	95	95
Gastrointestinal Hemorrhage	83	83
Blood Loss	71	71
Unspecified Vascular Problem	66	66
Perforation	64	64
Low Blood Pressure/ Hypotension	59	59
Aortic Valve Insufficiency/ Regurgitation	54	54
Renal Impairment	49	49
Embolism/Embolus	46	46
Bradycardia	45	45
Cardiac Tamponade	40	40
Great Vessel Perforation	35	35
Cardiogenic Shock	34	34
Ectopic Heartbeat	33	33
Air Embolism	33	33
Pericardial Effusion	32	32
Mitral Valve Insufficiency/ Regurgitation	28	28
No Known Impact Or Consequence To Patient	26	26
Respiratory Failure	24	24
Hemostasis	24	24
Anemia	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Obstruction/Occlusion	18	18
Valvular Insufficiency/ Regurgitation	18	18
Bacterial Infection	18	18
Retroperitoneal Hemorrhage	15	15
Asystole	14	14