TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
CIRCULATORY TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
GISH BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
MAQUET CARDIOPULMONARY AG
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
SORIN GROUP ITALIA S.R.L
	SUBSTANTIALLY EQUIVALENT	2
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	52	52
2015	25	25
2016	6	6
2017	3	3
2018	4	4
2019	10	10
2020	6	6
2021	12	13
2022	7	7
2023	7	7
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	25	25
Fluid/Blood Leak	14	14
Air/Gas in Device	12	12
Other (for use when an appropriate device code cannot be identified)	9	9
Obstruction of Flow	7	7
Infusion or Flow Problem	7	7
Air Leak	6	6
Break	5	5
Gas/Air Leak	5	5
Pressure Problem	4	4
Device Operates Differently Than Expected	4	4
Device Inoperable	3	3
Disconnection	3	3
Collapse	3	3
Component(s), broken	3	3
Detachment Of Device Component	3	3
Device Dislodged or Dislocated	3	4
Filtration Problem	2	2
Electrical /Electronic Property Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Positioning Problem	2	2
Crack	2	2
Misassembled	2	2
Nonstandard Device	2	2
Improper or Incorrect Procedure or Method	2	3
Increase in Pressure	2	2
Defective Component	2	2
Device Displays Incorrect Message	2	2
Detachment of Device or Device Component	1	1
Device Disinfection Or Sterilization Issue	1	1
Device Markings/Labelling Problem	1	1
Device Packaging Compromised	1	1
Structural Problem	1	1
Defective Device	1	1
Component Missing	1	1
Device Issue	1	1
Device Damaged Prior to Use	1	1
Difficult to Remove	1	1
Short Fill	1	1
Unsealed Device Packaging	1	1
Misconnection	1	1
Fracture	1	1
Material Fragmentation	1	1
Gas Output Problem	1	1
Excess Flow or Over-Infusion	1	1
Material Disintegration	1	1
Coagulation in Device or Device Ingredient	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Torn Material	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Free or Unrestricted Flow	1	1
Environmental Particulates	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	47	47
No Patient Involvement	34	34
No Clinical Signs, Symptoms or Conditions	22	23
No Consequences Or Impact To Patient	12	12
No Patient involvement	9	9
Cardiac Arrest	4	4
Death	4	4
Hemorrhage/Bleeding	4	4
No Information	2	2
Insufficient Information	1	1
Low Blood Pressure/ Hypotension	1	1
Paralysis	1	1
Thrombus	1	1
Hypovolemia	1	1
Fungal Infection	1	1
Low Oxygen Saturation	1	1
Blood Loss	1	1
Abdominal Distention	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Circulatory Technology Inc	II	Mar-01-2018
2	Circulatory Technology Inc	III	Oct-07-2016
3	Circulatory Technology Inc	II	Sep-15-2016
4	Circulatory Technology Inc	II	Jun-27-2016
5	Circulatory Technology Inc	II	Apr-13-2010
6	Circulatory Technology Inc.	II	Jun-15-2021
7	Datascope Corporation	II	May-08-2018
8	Maquet Medical Systems USA	II	May-26-2023
9	Medtronic Perfusion Systems	I	Mar-17-2021
10	Medtronic Perfusion Systems	II	Feb-20-2018
11	Terumo Cardiovascular Corporation	II	Aug-04-2011