TPLC - Total Product Life Cycle

• Device: filter, blood, cardiopulmonary bypass, arterial line
• Product Code: DTM
• Regulation Number: 870.4260
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
GISH BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CARDIOPULMONARY AG
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC PERFUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PAREXELINTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TRANSMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	64	64
2015	34	34
2016	27	27
2017	15	15
2018	23	23
2019	5	5
2020	1	1
2021	1	1
2022	4	4
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	78	78
Fluid/Blood Leak	51	51
Device Contamination with Chemical or Other Material	16	16
Particulates	14	14
Device Operates Differently Than Expected	11	11
Other (for use when an appropriate device code cannot be identified)	5	5
Crack	5	5
Break	4	4
Occlusion Within Device	4	4
Out-Of-Box Failure	3	3
Infusion or Flow Problem	3	3
Device Damaged Prior to Use	2	2
Filtration Problem	2	2
Improper Flow or Infusion	2	2
Pressure Problem	2	2
Complete Blockage	2	2
Fracture	2	2
Partial Blockage	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Increase in Pressure	1	1
Failure to Prime	1	1
Device Inoperable	1	1
Use of Device Problem	1	1
Coagulation in Device or Device Ingredient	1	1
Component(s), broken	1	1
Contamination	1	1
Device Expiration Issue	1	1
Restricted Flow rate	1	1
Difficult to Fold, Unfold or Collapse	1	1
Insufficient Information	1	1
Device Handling Problem	1	1
Noise, Audible	1	1
Free or Unrestricted Flow	1	1
Contamination /Decontamination Problem	1	1
Connection Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	65	65
No Patient Involvement	63	63
No Consequences Or Impact To Patient	14	14
No Information	12	12
No Clinical Signs, Symptoms or Conditions	7	7
No Patient involvement	5	5
Thrombus	3	3
Blood Loss	3	3
Low Oxygen Saturation	2	2
Rupture	1	1
Brain Injury	1	1
Hyperglycemia	1	1
Seizures	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc. Cardiac Rhythm Disease Management	II	Aug-14-2013
2	Medtronic Perfusion Systems	II	Dec-17-2019
3	Terumo Cardiovascular Systems Corporation	II	Sep-20-2013