TPLC - Total Product Life Cycle

• Device: oxygenator, long term support greater than 6 hours
• Regulation Description: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
• Product Code: BYS
• Regulation Number: 870.4100
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MC3 INC.
	SUBSTANTIALLY EQUIVALENT	1
MC3 INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1	1
2021	5	5
2022	2	2
2023	20	20
2024	42	42
2025	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	27	27
Infusion or Flow Problem	16	16
Mechanical Problem	8	8
Air/Gas in Device	6	6
Crack	3	3
Obstruction of Flow	3	3
Adverse Event Without Identified Device or Use Problem	3	3
No Apparent Adverse Event	2	2
Increase in Pressure	2	2
Leak/Splash	1	1
Insufficient Information	1	1
Contamination	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
Partial Blockage	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
Ischemia	7	7
Embolism/Embolus	7	7
Thrombosis/Thrombus	7	7
Insufficient Information	4	4
Hemorrhage/Bleeding	3	3
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemolysis	1	1
Unspecified Blood or Lymphatic problem	1	1
Alteration in Body Temperature	1	1
Respiratory Insufficiency	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mc3 Inc	II	Mar-19-2024