TPLC - Total Product Life Cycle

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Device	subcutaneous implanted apheresis port
Regulation Description	Subcutaneous, implanted, intravascular infusion port and catheter.
Definition	A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
Product Code	PTD
Regulation Number	880.5965
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	38	40
Blocked Connection	19	20
Suction Problem	18	18
Difficult to Flush	15	16
Obstruction of Flow	15	16
Fluid/Blood Leak	10	12
Expulsion	6	6
Migration	6	6
Device Appears to Trigger Rejection	6	6
Restricted Flow rate	5	5
Fracture	5	5
Reflux within Device	4	6
Air/Gas in Device	4	4
Device Tipped Over	3	3
Improper or Incorrect Procedure or Method	3	3
Disconnection	2	2
Material Puncture/Hole	2	3
Material Separation	2	2
Loss of or Failure to Bond	2	2
Material Split, Cut or Torn	1	1
Malposition of Device	1	1
Device Markings/Labelling Problem	1	1
Unsealed Device Packaging	1	1
Detachment of Device or Device Component	1	1
Illegible Information	1	1
Difficult to Open or Close	1	2
Loose or Intermittent Connection	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	56
Unspecified Infection	20	20
Thrombosis/Thrombus	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Pain	7	9
Skin Erosion	6	6
Hemorrhage/Bleeding	4	6
Air Embolism	2	2
Hematoma	2	2
Scar Tissue	2	2
Low Blood Pressure/ Hypotension	2	2
Arrhythmia	1	1
Stroke/CVA	1	1
Sepsis	1	1
Obstruction/Occlusion	1	1
Rash	1	1
Discomfort	1	1
Tachycardia	1	1
Swelling/ Edema	1	1
Bacterial Infection	1	1
Pulmonary Embolism	1	1
Bruise/Contusion	1	1