TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
38	33	48	61	50	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	39214	39221
Mechanical Problem	7050	7050
Infusion or Flow Problem	4719	4719
Pumping Problem	4610	4610
Battery Problem	3968	3971
Electrical Power Problem	2736	2736
Pumping Stopped	2360	2360
Disconnection	2234	2234
Complete Loss of Power	2215	2215
Electrical /Electronic Property Problem	1961	1961
Insufficient Information	1825	1827
No Apparent Adverse Event	1645	1645
Power Problem	1447	1447
Material Integrity Problem	1424	1424
Display or Visual Feedback Problem	940	940
Use of Device Problem	930	930
Communication or Transmission Problem	884	884
Device Difficult to Setup or Prepare	776	776
Material Deformation	729	729
Decreased Pump Speed	729	729
Material Twisted/Bent	720	720
Improper or Incorrect Procedure or Method	688	688
Break	663	663
Failure to Charge	568	568
Obstruction of Flow	468	468
Noise, Audible	430	431
Connection Problem	428	428
Material Split, Cut or Torn	412	413
Overheating of Device	293	293
Corroded	235	235
Display Difficult to Read	226	226
Increase in Suction	224	224
Failure to Pump	222	222
Failure to Power Up	204	204
Fluid/Blood Leak	202	202
Failure to Align	197	197
No Audible Alarm	193	194
Malposition of Device	177	177
Contamination /Decontamination Problem	177	177
Electromagnetic Interference	168	168
Data Problem	164	164
Electro-Static Discharge	130	130
No Display/Image	125	125
Unintended Electrical Shock	115	115
Failure to Interrogate	114	114
Dull, Blunt	101	101
Low Audible Alarm	101	101
Device Alarm System	100	101
Alarm Not Visible	100	100
Material Discolored	99	99

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	29450	29458
Insufficient Information	7079	7081
Heart Failure/Congestive Heart Failure	4792	4792
Hemorrhage/Bleeding	3866	3867
Bacterial Infection	3794	3795
Thrombosis/Thrombus	3766	3766
Unspecified Infection	3195	3195
Skin Infection	2850	2850
Gastrointestinal Hemorrhage	2775	2775
Arrhythmia	2449	2449
Renal Failure	1800	1800
Hemolysis	1784	1784
Stroke/CVA	1768	1768
Respiratory Failure	1395	1398
Tachycardia	1323	1323
Sepsis	1304	1304
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1303	1303
High Blood Pressure/ Hypertension	1272	1272
Dyspnea	1196	1196
Hypervolemia	1065	1065
Intracranial Hemorrhage	1054	1054
Hemorrhagic Stroke	966	966
Multiple Organ Failure	940	941
Unspecified Nervous System Problem	910	910
Cardiac Arrest	876	876
Ischemia Stroke	872	872
Lactate Dehydrogenase Increased	852	852
Syncope/Fainting	843	843
Dizziness	792	792
Anemia	712	712
Aortic Valve Insufficiency/ Regurgitation	674	674
Low Blood Pressure/ Hypotension	668	668
Fever	648	650
Muscle Weakness	598	598
Ventricular Fibrillation	573	573
Pneumonia	561	561
Fatigue	547	547
Atrial Fibrillation	518	518
Hematoma	498	498
Cardiogenic Shock	498	498
Renal Impairment	496	496
Loss of consciousness	425	425
Fall	415	415
Chest Pain	408	408
Pain	392	392
Obstruction/Occlusion	383	383
Melena	383	383
Hematuria	381	381
Drug Resistant Bacterial Infection	372	373
Purulent Discharge	368	369