TPLC - Total Product Life Cycle

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Device	heat-exchanger, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass heat exchanger.
Product Code	DTR
Regulation Number	870.4240
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	43	49
Mechanical Problem	11	17
Leak/Splash	8	14
Insufficient Device Problem Information	8	8
Infusion or Flow Problem	8	8
Tear, Rip or Hole in Device Packaging	8	8
No Apparent Adverse Event	7	10
Air/Gas in Device	5	5
Improper Flow or Infusion	5	5
Device Contaminated During Manufacture or Shipping	4	4
Unintended Movement	3	3
Use of Device Problem	3	3
Device Dislodged or Dislocated	3	3
Device Alarm System	2	2
Increased Sensitivity	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Contamination	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Separation	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Unexpected Shutdown	1	1
Output Problem	1	1
Failure to Deliver	1	1
Unintended Application Program Shut Down	1	1
Key or Button Unresponsive/not Working	1	1
Visual Prompts will not Clear	1	1
Backflow	1	1
Gas/Air Leak	1	1
Excess Flow or Over-Infusion	1	1
Particulates	1	1
Decrease in Pressure	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Increase in Pressure	1	1
Connection Problem	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	107	113
Hemorrhage/Blood Loss/Bleeding	13	13
Insufficient Information	8	8
Electrolyte Imbalance	2	2
Cardiac Arrest	1	1
Bacterial Infection	1	1
No Consequences Or Impact To Patient	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Maquet Medical Systems USA	II	May-26-2023