TPLC - Total Product Life Cycle

• Device: reservoir, blood, cardiopulmonary bypass
• Product Code: DTN
• Regulation Number: 870.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MEDTRONIC CARDIAC SURGERY
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	6	6
2021	12	13
2022	7	7
2023	8	8
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Air/Gas in Device	15	15
Obstruction of Flow	7	7
Gas/Air Leak	3	3
Leak/Splash	2	2
Collapse	2	2
Misassembled	2	2
Device Dislodged or Dislocated	2	3
Nonstandard Device	2	2
Break	1	1
Device Damaged Prior to Use	1	1
Device Markings/Labelling Problem	1	1
Filtration Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inflation Problem	1	1
Misconnection	1	1
Packaging Problem	1	1
Detachment of Device or Device Component	1	1
Free or Unrestricted Flow	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Improper or Incorrect Procedure or Method	1	2
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	28	29
No Patient Involvement	6	6
Hemorrhage/Bleeding	4	4
Cardiac Arrest	3	3
No Consequences Or Impact To Patient	3	3
No Known Impact Or Consequence To Patient	2	2
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Circulatory Technology Inc.	II	Jun-15-2021
2	Maquet Medical Systems USA	II	May-26-2023
3	Medtronic Perfusion Systems	I	Mar-17-2021