TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
38	33	48	61	50	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	37774	37781
Mechanical Problem	6640	6640
Pumping Problem	4483	4483
Infusion or Flow Problem	4425	4425
Battery Problem	3904	3907
Electrical Power Problem	2546	2546
Pumping Stopped	2234	2234
Disconnection	2093	2093
Complete Loss of Power	2070	2070
Electrical /Electronic Property Problem	1782	1782
Insufficient Information	1722	1724
No Apparent Adverse Event	1524	1524
Power Problem	1382	1382
Material Integrity Problem	1347	1347
Display or Visual Feedback Problem	904	904
Use of Device Problem	814	814
Communication or Transmission Problem	806	806
Device Difficult to Setup or Prepare	726	726
Decreased Pump Speed	701	701
Material Deformation	693	693
Material Twisted/Bent	692	692
Break	657	657
Improper or Incorrect Procedure or Method	631	631
Failure to Charge	514	514
Obstruction of Flow	444	444
Connection Problem	418	418
Material Split, Cut or Torn	407	408
Noise, Audible	402	403
Overheating of Device	271	271
Failure to Pump	218	218
Display Difficult to Read	212	212
Increase in Suction	212	212
Corroded	208	208
Fluid/Blood Leak	196	196
Failure to Power Up	193	193
Failure to Align	192	192
No Audible Alarm	179	180
Malposition of Device	171	171
Contamination /Decontamination Problem	170	170
Data Problem	150	150
Electromagnetic Interference	149	149
No Display/Image	118	118
Electro-Static Discharge	117	117
Failure to Interrogate	104	104
Unintended Electrical Shock	101	101
Dull, Blunt	97	97
Low Audible Alarm	96	96
Material Discolored	96	96
Device Alarm System	96	97
Alarm Not Visible	95	95

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27893	27901
Insufficient Information	6735	6737
Heart Failure/Congestive Heart Failure	4601	4601
Hemorrhage/Bleeding	3736	3737
Bacterial Infection	3663	3664
Thrombosis/Thrombus	3622	3622
Unspecified Infection	3068	3068
Skin Infection	2739	2739
Gastrointestinal Hemorrhage	2673	2673
Arrhythmia	2383	2383
Hemolysis	1756	1756
Renal Failure	1733	1733
Stroke/CVA	1685	1685
Respiratory Failure	1363	1366
Tachycardia	1263	1263
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1262	1262
Sepsis	1260	1260
High Blood Pressure/ Hypertension	1241	1241
Dyspnea	1148	1148
Hypervolemia	1002	1002
Intracranial Hemorrhage	1002	1002
Hemorrhagic Stroke	937	937
Multiple Organ Failure	900	901
Unspecified Nervous System Problem	878	878
Cardiac Arrest	825	825
Ischemia Stroke	823	823
Lactate Dehydrogenase Increased	822	822
Syncope/Fainting	816	816
Dizziness	756	756
Anemia	689	689
Low Blood Pressure/ Hypotension	643	643
Aortic Valve Insufficiency/ Regurgitation	627	627
Fever	627	629
Muscle Weakness	575	575
Pneumonia	533	533
Fatigue	531	531
Ventricular Fibrillation	527	527
Atrial Fibrillation	497	497
Hematoma	480	480
Renal Impairment	479	479
Cardiogenic Shock	467	467
Loss of consciousness	408	408
Fall	404	404
Chest Pain	383	383
Pain	380	380
Hematuria	373	373
Melena	365	365
Obstruction/Occlusion	363	363
Drug Resistant Bacterial Infection	361	362
Thromboembolism	357	357