TPLC - Total Product Life Cycle

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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

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
Crack	6	6
Other (for use when an appropriate device code cannot be identified)	5	5
Break	4	4
Occlusion Within Device	4	4
Out-Of-Box Failure	3	3
Infusion or Flow Problem	3	3
Improper Flow or Infusion	2	2
Pressure Problem	2	2
Filtration Problem	2	2
Device Damaged Prior to Use	2	2
Complete Blockage	2	2
Fracture	2	2
Mechanical Problem	1	1
Use of Device Problem	1	1
Restricted Flow rate	1	1
Difficult to Fold, Unfold or Collapse	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Expiration Issue	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Failure to Prime	1	1
Contamination of Device Ingredient or Reagent	1	1
Partial Blockage	1	1
Free or Unrestricted Flow	1	1
Connection Problem	1	1
Coagulation in Device or Device Ingredient	1	1
Component(s), broken	1	1
Loose or Intermittent Connection	1	1
Device Handling Problem	1	1
Increase in Pressure	1	1
Device Inoperable	1	1
Noise, Audible	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	8	8
No Patient involvement	5	5
Blood Loss	3	3
Thrombus	3	3
Low Oxygen Saturation	2	2
Seizures	1	1
Brain Injury	1	1
Rupture	1	1
Hyperglycemia	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