TPLC - Total Product Life Cycle

show TPLC since

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
34	48	38	33	48	56

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	52029	52029
Mechanical Problem	6592	6592
Pumping Problem	6487	6487
Battery Problem	5198	5198
Infusion or Flow Problem	4119	4119
Power Problem	3700	3700
Pumping Stopped	3164	3164
Electrical Power Problem	2170	2170
Complete Loss of Power	1964	1964
Disconnection	1808	1808
Electrical /Electronic Property Problem	1737	1737
Break	1725	1725
Material Integrity Problem	1592	1592
Insufficient Information	1529	1529
Material Twisted/Bent	1280	1280
Connection Problem	1070	1070
Decreased Pump Speed	1030	1030
No Apparent Adverse Event	1021	1021
Obstruction of Flow	953	953
Material Split, Cut or Torn	911	911
Display or Visual Feedback Problem	816	816
Communication or Transmission Problem	729	729
Use of Device Problem	662	662
Material Deformation	619	619
Device Difficult to Setup or Prepare	616	616
Improper or Incorrect Procedure or Method	513	513
Noise, Audible	416	416
Failure to Charge	301	301
Overheating of Device	287	287
Increase in Suction	277	277
Malposition of Device	261	261
Failure to Pump	221	221
Appropriate Term/Code Not Available	220	220
No Audible Alarm	213	213
Loss of Power	200	200
Fluid/Blood Leak	198	198
Data Problem	194	194
Naturally Worn	171	171
Device Alarm System	171	171
Failure to Power Up	168	168
Display Difficult to Read	167	167
Failure to Align	160	160
Output Problem	147	147
No Display/Image	131	131
Contamination /Decontamination Problem	128	128
Corroded	121	121
Electromagnetic Interference	111	111
High Readings	106	106
Electro-Static Discharge	106	106
Deformation Due to Compressive Stress	103	103

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23465	23465
No Known Impact Or Consequence To Patient	6708	6708
Blood Loss	6483	6483
Unspecified Infection	6052	6052
Insufficient Information	5373	5373
No Consequences Or Impact To Patient	4558	4558
Bacterial Infection	4421	4421
Heart Failure/Congestive Heart Failure	3944	3944
Death	3783	3783
Hemorrhage/Bleeding	3710	3710
Thrombosis/Thrombus	3481	3481
Stroke/CVA	2935	2935
Hemolysis	2864	2864
Arrhythmia	2734	2734
Skin Infection	2418	2418
Gastrointestinal Hemorrhage	2399	2399
Renal Failure	2187	2187
Thrombus	2045	2045
Sepsis	1957	1957
Respiratory Failure	1883	1883
High Blood Pressure/ Hypertension	1258	1258
Dyspnea	1204	1204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1172	1172
Tachycardia	1109	1109
Anemia	1083	1083
Intracranial Hemorrhage	1030	1030
Multiple Organ Failure	983	983
Hypervolemia	918	918
Hemorrhagic Stroke	847	847
Dizziness	827	827
Unspecified Nervous System Problem	802	802
Cardiac Arrest	801	801
Lactate Dehydrogenase Increased	782	782
Fever	715	715
Neurological Deficit/Dysfunction	691	691
Hemorrhage, Cerebral	687	687
Low Blood Pressure/ Hypotension	678	678
Ischemia Stroke	676	676
Syncope/Fainting	673	673
Heart Failure	653	653
Hematuria	627	627
Thromboembolism	622	622
Hematoma	606	606
Fatigue	587	587
Thrombosis	553	553
Atrial Fibrillation	548	548
Muscle Weakness	529	529
Cardiogenic Shock	525	525
Pneumonia	507	507
Aortic Valve Insufficiency/ Regurgitation	475	475