TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	50	50
Obstruction of Flow	17	17
Infusion or Flow Problem	16	16
Mechanical Problem	13	13
Air/Gas in Device	12	12
Material Deformation	6	6
Gas Output Problem	6	6
Crack	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Puncture/Hole	3	3
Increase in Pressure	3	3
No Apparent Adverse Event	2	2
Leak/Splash	1	1
Break	1	1
Device Alarm System	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
Material Separation	1	1
Electrical /Electronic Property Problem	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	93
Hemorrhage/Bleeding	12	12
Ischemia	7	7
Embolism/Embolus	7	7
Thrombosis/Thrombus	7	7
Insufficient Information	5	5
Hemolysis	3	3
Unspecified Infection	2	2
Hemorrhagic Stroke	2	2
Ischemia Stroke	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Blood or Lymphatic problem	1	1
Alteration in Body Temperature	1	1
Hypoxia	1	1
Respiratory Insufficiency	1	1

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