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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
Regulation Description Isolated kidney perfusion and transport system and accessories.
Product CodeKDN
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
BRIDGE TO LIFE LTD.
  SUBSTANTIALLY EQUIVALENT 2
PARAGONIX TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PRAGONIX TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT - KIT 1
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 1
UNITED THERAPEUTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XVIVO PERFUSION AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 6 6
2018 4 4
2019 3 3
2020 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 12 12
Device Emits Odor 3 3
Microbial Contamination of Device 3 3
Device Contamination With Biological Material 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Contamination 1 1
Product Quality Problem 1 1
Device Displays Incorrect Message 1 1
Contamination of Device Ingredient or Reagent 1 1
Insufficient Information 1 1
No Audible Alarm 1 1
Pumping Stopped 1 1
Hole In Material 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 6 6
No Consequences Or Impact To Patient 4 4
Fungal Infection 1 1
Abscess 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Sepsis 1 1
No Information 1 1
No Code Available 1 1
Bacterial Infection 1 1
Death 1 1
Unspecified Infection 1 1
Urinary Tract Infection 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Organ Recovery Systems, Inc. II Mar-04-2020
2 Preservation Solutions, Inc. II Apr-16-2018
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