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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessory equipment, cardiopulmonary bypass
Product CodeKRI
Regulation Number 870.4200
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Mechanical Problem 1 1
Crack 1 1
Defective Device 1 1
Device Dislodged or Dislocated 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 6 6
Insufficient Information 3 3
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiopulmonary Ag II May-04-2018
2 Maquet Cardiovascular Us Sales, Llc II Aug-12-2020
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