TPLC - Total Product Life Cycle

show TPLC since

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
48	38	33	48	61	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	41646	41646
Mechanical Problem	6808	6808
Pumping Problem	5140	5140
Battery Problem	4371	4371
Infusion or Flow Problem	4268	4268
Pumping Stopped	2574	2574
Electrical Power Problem	2291	2291
Complete Loss of Power	1929	1929
Disconnection	1827	1827
Power Problem	1776	1776
Electrical /Electronic Property Problem	1704	1704
Insufficient Information	1563	1563
Material Integrity Problem	1433	1433
No Apparent Adverse Event	1201	1201
Material Twisted/Bent	943	943
Break	942	942
Decreased Pump Speed	864	864
Display or Visual Feedback Problem	826	826
Communication or Transmission Problem	736	736
Material Split, Cut or Torn	703	703
Device Difficult to Setup or Prepare	642	642
Use of Device Problem	637	637
Connection Problem	626	626
Obstruction of Flow	616	616
Material Deformation	602	602
Improper or Incorrect Procedure or Method	548	548
Noise, Audible	398	398
Failure to Charge	357	357
Overheating of Device	271	271
Increase in Suction	250	250
Failure to Pump	218	218
Malposition of Device	206	206
No Audible Alarm	206	206
Fluid/Blood Leak	196	196
Failure to Power Up	182	182
Failure to Align	177	177
Display Difficult to Read	175	175
Data Problem	158	158
Corroded	148	148
Contamination /Decontamination Problem	139	139
Device Alarm System	125	125
No Display/Image	123	123
Electromagnetic Interference	121	121
Electro-Static Discharge	113	113
Deformation Due to Compressive Stress	98	98
Loss of Power	96	96
Failure to Interrogate	95	95
Appropriate Term/Code Not Available	94	94
Low Audible Alarm	93	93
Alarm Not Visible	90	90

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	25031	25031
Insufficient Information	5830	5830
Heart Failure/Congestive Heart Failure	4193	4193
Unspecified Infection	4172	4172
Bacterial Infection	3912	3912
Hemorrhage/Bleeding	3811	3811
No Consequences Or Impact To Patient	3649	3649
Thrombosis/Thrombus	3638	3638
Skin Infection	2512	2512
Gastrointestinal Hemorrhage	2506	2506
Arrhythmia	2458	2458
Blood Loss	2363	2363
Hemolysis	2124	2124
Stroke/CVA	2088	2088
Renal Failure	1909	1909
Death	1706	1706
Respiratory Failure	1545	1545
Sepsis	1443	1443
High Blood Pressure/ Hypertension	1256	1256
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1219	1219
Tachycardia	1169	1169
Dyspnea	1148	1148
Intracranial Hemorrhage	1003	1003
No Known Impact Or Consequence To Patient	999	999
Hypervolemia	934	934
Hemorrhagic Stroke	882	882
Multiple Organ Failure	843	843
Unspecified Nervous System Problem	825	825
Anemia	812	812
Lactate Dehydrogenase Increased	811	811
Thrombus	796	796
Cardiac Arrest	785	785
Dizziness	774	774
Ischemia Stroke	742	742
Syncope/Fainting	727	727
Fever	684	684
Low Blood Pressure/ Hypotension	652	652
Hematoma	547	547
Muscle Weakness	547	547
Fatigue	536	536
Atrial Fibrillation	531	531
Aortic Valve Insufficiency/ Regurgitation	524	524
Pneumonia	512	512
Cardiogenic Shock	495	495
Ventricular Fibrillation	482	482
Thromboembolism	476	476
Hematuria	472	472
Renal Impairment	447	447
Loss of consciousness	414	414
Pain	410	410