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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, perfusion, kidney
Product CodeKDN
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
BRIDGE TO LIFE LTD.
  SUBSTANTIALLY EQUIVALENT 2
INSTITUT GEORGES LOPEZ
  SUBSTANTIALLY EQUIVALENT 1
PARAGONIX TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4
PRAGONIX TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT - KIT 1
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 2
XVIVO PERFUSION AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 9 9
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 11 11
Device Markings/Labelling Problem 1 1
No Audible Alarm 1 1
Pumping Stopped 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6 6
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Organ Recovery Systems, Inc. II Mar-04-2020
2 Waters Medical Systems LLC II Apr-27-2022
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