TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Air/Gas in Device	12	12
Obstruction of Flow	6	6
Gas/Air Leak	5	5
Infusion or Flow Problem	3	3
Device Dislodged or Dislocated	2	3
Collapse	2	2
Leak/Splash	2	2
Misassembled	2	2
Nonstandard Device	2	2
Pressure Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Break	1	1
Short Fill	1	1
Improper or Incorrect Procedure or Method	1	2
Device Damaged Prior to Use	1	1
Defective Component	1	1
Misconnection	1	1
Gas Output Problem	1	1
Filtration Problem	1	1
Free or Unrestricted Flow	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Material Twisted/Bent	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22	23
No Patient Involvement	11	11
No Known Impact Or Consequence To Patient	6	6
Cardiac Arrest	3	3
Hemorrhage/Bleeding	3	3
No Consequences Or Impact To Patient	3	3
Hypovolemia	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Circulatory Technology Inc.	II	Jun-15-2021
2	Maquet Medical Systems USA	II	May-26-2023
3	Medtronic Perfusion Systems	I	Mar-17-2021