TPLC - Total Product Life Cycle

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Device	dual lumen ecmo cannula
Definition	Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Product Code	PZS
Regulation Number	870.4100
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	25	27
Adverse Event Without Identified Device or Use Problem	10	10
Use of Device Problem	8	8
Crack	6	6
Break	3	3
Unintended Movement	3	3
Air/Gas in Device	3	3
Material Deformation	3	3
Positioning Problem	2	2
Migration	2	2
Material Frayed	1	1
Malposition of Device	1	1
Material Puncture/Hole	1	1
Obstruction of Flow	1	1
Material Separation	1	1
Material Protrusion/Extrusion	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22	24
Pericardial Effusion	10	10
Hemorrhage/Bleeding	8	8
Air Embolism	6	6
Perforation of Vessels	6	6
Perforation	4	4
Cardiac Arrest	4	4
Insufficient Information	4	4
Cardiac Tamponade	3	3
Low Blood Pressure/ Hypotension	3	3
Brain Injury	2	2
Bradycardia	2	2
Respiratory Insufficiency	2	2
Low Oxygen Saturation	2	2
Death	1	1
Arrhythmia	1	1
Hematoma	1	1
Valvular Insufficiency/ Regurgitation	1	1
Diminished Pulse Pressure	1	1
No Known Impact Or Consequence To Patient	1	1
Foreign Body In Patient	1	1
Cardiac Perforation	1	1
Exposure to Body Fluids	1	1
Swelling/ Edema	1	1
Shock	1	1
Tissue Damage	1	1
Convulsion/Seizure	1	1
Hypoxia	1	1
Respiratory Failure	1	1
Intimal Dissection	1	1