TPLC - Total Product Life Cycle

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Device	dual lumen ecmo cannula
Regulation Description	Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
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	24	24
Mechanical Problem	16	16
Air/Gas in Device	14	14
Crack	12	12
Obstruction of Flow	9	9
Use of Device Problem	8	8
Material Puncture/Hole	5	5
Material Deformation	5	5
Material Integrity Problem	4	4
Fluid/Blood Leak	4	4
Unintended Movement	3	3
Break	2	2
Positioning Problem	2	2
Migration	2	2
Material Frayed	1	1
Malposition of Device	1	1
Gas/Air Leak	1	1
Material Separation	1	1
Material Protrusion/Extrusion	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	39	41
Hemorrhage/Bleeding	19	19
Pericardial Effusion	10	10
Perforation	8	8
Air Embolism	6	6
Perforation of Vessels	6	6
Unspecified Infection	5	5
Insufficient Information	5	5
Brain Injury	4	4
Embolism/Embolus	4	4
Cardiac Arrest	4	4
Thrombosis/Thrombus	4	4
Respiratory Insufficiency	4	4
Cardiac Tamponade	3	3
Shock	3	3
Low Blood Pressure/ Hypotension	3	3
Multiple Organ Failure	2	2
Septic Shock	2	2
Viral Infection	2	2
Bradycardia	2	2
Hypoxia	2	2
Low Oxygen Saturation	2	2
Cerebral Edema	2	2
Arrhythmia	1	1
Stroke/CVA	1	1
Hematoma	1	1
Diminished Pulse Pressure	1	1
Valvular Insufficiency/ Regurgitation	1	1
Cardiac Perforation	1	1
Foreign Body In Patient	1	1
Exposure to Body Fluids	1	1
Swelling/ Edema	1	1
Respiratory Failure	1	1