TPLC - Total Product Life Cycle

• Device: sucker, cardiotomy return, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass cardiotomy return sucker.
• Product Code: DTS
• Regulation Number: 870.4420
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	3	3
2020	2	2
2021	11	12
2022	11	11
2023	12	14
2024	20	20
2025	17	17
2026	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Obstruction of Flow	16	16
Material Deformation	13	13
Disconnection	11	11
Detachment of Device or Device Component	8	8
Mechanical Problem	7	8
Adverse Event Without Identified Device or Use Problem	7	7
Material Separation	5	5
Crack	3	3
Material Puncture/Hole	3	4
Material Integrity Problem	3	3
Delivered as Unsterile Product	3	3
Complete Blockage	2	2
Contamination	2	2
Material Protrusion/Extrusion	2	3
Off-Label Use	1	1
Restricted Flow rate	1	1
Component Missing	1	1
No Apparent Adverse Event	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	64	67
Foreign Body In Patient	4	4
Unspecified Infection	3	3
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pseudoaneurysm	2	2
No Consequences Or Impact To Patient	2	2
Hemorrhage/Bleeding	2	2
Stroke/CVA	1	1
Perforation	1	1
Atrial Fibrillation	1	1
Mitral Valve Insufficiency/ Regurgitation	1	2
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Renal Failure	1	1
Hypovolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Perfusion Systems	II	May-10-2024