TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
48	38	33	48	61	32

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	42922	42922
Mechanical Problem	7112	7112
Pumping Problem	5298	5298
Infusion or Flow Problem	4501	4501
Battery Problem	4491	4491
Pumping Stopped	2660	2660
Electrical Power Problem	2452	2452
Complete Loss of Power	2061	2061
Disconnection	1959	1959
Electrical /Electronic Property Problem	1848	1848
Power Problem	1843	1843
Insufficient Information	1659	1659
Material Integrity Problem	1475	1475
No Apparent Adverse Event	1277	1277
Break	961	961
Material Twisted/Bent	956	956
Decreased Pump Speed	894	894
Display or Visual Feedback Problem	873	873
Communication or Transmission Problem	780	780
Use of Device Problem	740	740
Material Split, Cut or Torn	709	709
Device Difficult to Setup or Prepare	675	675
Material Deformation	647	647
Connection Problem	637	637
Obstruction of Flow	633	633
Improper or Incorrect Procedure or Method	566	566
Noise, Audible	417	417
Failure to Charge	415	415
Overheating of Device	289	289
Increase in Suction	258	258
Failure to Pump	226	226
Malposition of Device	215	215
No Audible Alarm	213	213
Fluid/Blood Leak	208	208
Failure to Power Up	195	195
Failure to Align	187	187
Display Difficult to Read	183	183
Corroded	166	166
Data Problem	164	164
Contamination /Decontamination Problem	150	150
Electromagnetic Interference	132	132
Device Alarm System	132	132
No Display/Image	129	129
Electro-Static Discharge	119	119
Alarm Not Visible	101	101
Deformation Due to Compressive Stress	100	100
Failure to Interrogate	98	98
Appropriate Term/Code Not Available	96	96
Low Audible Alarm	96	96
Loss of Power	96	96

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	26341	26341
Insufficient Information	6124	6124
Heart Failure/Congestive Heart Failure	4423	4423
Unspecified Infection	4285	4285
Bacterial Infection	4045	4045
Hemorrhage/Bleeding	3929	3929
Thrombosis/Thrombus	3778	3778
No Consequences Or Impact To Patient	3649	3649
Skin Infection	2612	2612
Gastrointestinal Hemorrhage	2584	2584
Arrhythmia	2526	2526
Blood Loss	2363	2363
Hemolysis	2150	2150
Stroke/CVA	2142	2142
Renal Failure	1972	1972
Death	1706	1706
Respiratory Failure	1607	1607
Sepsis	1499	1499
High Blood Pressure/ Hypertension	1279	1279
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1251	1251
Tachycardia	1232	1232
Dyspnea	1203	1203
Intracranial Hemorrhage	1062	1062
No Known Impact Or Consequence To Patient	999	999
Hypervolemia	975	975
Hemorrhagic Stroke	918	918
Multiple Organ Failure	918	918
Unspecified Nervous System Problem	849	849
Lactate Dehydrogenase Increased	837	837
Cardiac Arrest	831	831
Anemia	831	831
Dizziness	808	808
Thrombus	796	796
Ischemia Stroke	785	785
Syncope/Fainting	771	771
Fever	699	699
Low Blood Pressure/ Hypotension	680	680
Muscle Weakness	571	571
Hematoma	568	568
Aortic Valve Insufficiency/ Regurgitation	567	567
Fatigue	562	562
Pneumonia	546	546
Atrial Fibrillation	543	543
Ventricular Fibrillation	521	521
Cardiogenic Shock	518	518
Thromboembolism	485	485
Hematuria	479	479
Renal Impairment	462	462
Loss of consciousness	429	429
Pain	421	421