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	42	42
Mechanical Problem	8	8
Improper Flow or Infusion	6	6
Infusion or Flow Problem	6	6
Insufficient Information	5	5
Tear, Rip or Hole in Device Packaging	5	5
Leak/Splash	4	4
Device Contaminated During Manufacture or Shipping	4	4
Air/Gas in Device	4	4
No Apparent Adverse Event	4	4
Material Puncture/Hole	3	3
Unintended Movement	3	3
Use of Device Problem	3	3
Device Dislodged or Dislocated	3	3
Increased Sensitivity	2	2
Defective Component	2	2
Therapeutic or Diagnostic Output Failure	2	2
Contamination	2	2
Gas/Air Leak	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Separation	2	2
Protective Measures Problem	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Device Alarm System	1	1
Pumping Stopped	1	1
Microbial Contamination of Device	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
Obstruction of Flow	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	85	85
Hemorrhage/Bleeding	13	13
Insufficient Information	8	8
Electrolyte Imbalance	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Cardiac Arrest	1	1
No Consequences Or Impact To Patient	1	1
Bacterial Infection	1	1

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